13 Other Considerations

1. For submitting a Malfunction report to CDER, these are the recommendations for data entry:
   • Patient tab: No data needs to be entered, Patient Initial element gets populated as None.
   • Product tab: Set the Malfunction field to Yes, enter one or more Malfunctions in the Malfunction Information section and enter the Device Problem codes in the Device tab of the Constituent Product.

     Note:

     If there are multiple malfunction reports, it is recommended to provide a summary of malfunction information in the Narrative.
   • Event tab: Enter No Adverse Event as Reported term to get the properly coded corresponding MedDRA term.
   • Analysis tab: Case Serious is set to No.
2. For submitting a Malfunction Similar Device report to CDER, the following are the recommendations for data entry:
   1. FDA recommends providing the following data for Similar Device Combination Products. Hence the FDA E2B(R2) 2.2 DTD report populates this data for Similar Device Combination Products.

      Element ID	Element Description
      B.4.k.4.1	Authorization/Application Number
      B.4.k.4.2	Country of authorization/application
      B.4.k.4.3	Name of holder/applicant
      B.4.k.20.FDA.4	Manufacturer
      B.4.k.20.FDA.4a	Device Manufacturer Name
      B.4.k.20.FDA.4b	Manufacturer Address
      B.4.k.20.FDA.4c	Manufacturer City
      B.4.k.20.FDA.4d	Manufacturer State
      B.4.k.20.FDA.4e	Manufacturer Country

   2. The following elements are not required for Similar Device Combination Products as the product was not administered, hence it is recommended to leave these fields blank:

      Element ID	Element Description
      B.4.k.2.4.FDA.1a	Expiration Date Format
      B.4.k.2.4.FDA.1b	Expiration Date
      B.4.k.2.FDA.5	Product available for evaluation
      B.4.k.2.6.FDA.1a	Product return date format
      B.4.k.2.6.FDA.1b	Product return date
      B.4.k.20.FDA.5	Model Number
      B.4.k.20.FDA.6	Catalog Number
      B.4.k.20.FDA.7	Serial Number
      B.4.k.20.FDA.8	Unique Identifier UDI#
      B.4.k.20.FDA.9a	Implanted Date Format
      B.4.k.20.FDA.9b	Implanted Date
      B.4.k.20.FDA.10a	Explanted Date Format
      B.4.k.20.FDA.10b	Explanted Date
      B.4.k.20.FDA.11a	Approximate age of device/product
      B.4.k.20.FDA.11b	Approximate age unit of device / product
      B.4.k.20.FDA.12	Single Use Device
      B.4.k.20.FDA.13a	Device Manufacture Date Format
      B.4.k.20.FDA.13b	Device Manufacture Date
      B.4.k.20.FDA.14.1a	Recall
      B.4.k.20.FDA.14.1b	Repair
      B.4.k.20.FDA.14.1c	Replace
      B.4.k.20.FDA.14.1d	Relabeling
      B.4.k.20.FDA.14.1e	Notification
      B.4.k.20.FDA.14.1f	Inspection
      B.4.k.20.FDA.14.1g	Patient monitoring
      B.4.k.20.FDA.14.1h	Modification / Adjustment
      B.4.k.20.FDA.14.1i	Other
      B.4.k.20.FDA.15	Device Usage
      B.4.k.20.FDA.16	Device Lot Number
      B.4.k.20.FDA.18.1a	Correction
      B.4.k.20.FDA.18.1b	Additional Information
      B.4.k.20.FDA.18.1c	Response to FDA request
      B.4.k.20.FDA.18.1d	Device Evaluation
      B.4.k.20.FDA.19	Device Problem and evaluation codes
      B.4.k.20.FDA.19.1a	Evaluation Type
      B.4.k.20.FDA.19.1b	Evaluation Value
      B.4.k.20.FDA.20	Operator of the Device