MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PRIMAPORE ADHESIVE 8X15CM CTN 20; APPLICATOR, ABSORBENT TIPPED, STERILE

Model Number	66000318
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that the caregiver contacted baxter customer service via phone to report that the home patient had a reaction to the dressing, 15x8cm primapore.The caregiver stated they will use 4x4 sponges to cover the wound until the skin is recovered.No additional information was provided.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that the caregiver contacted baxter customer service via phone to report that the home patient had a reaction to the dressing, 15x8cm primapore.The caregiver stated they will use 4x4 sponges to cover the wound until the skin is recovered.No additional information was provided.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).Smith & nephew is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew, or its employees caused or contributed to the potential event described in this report.
Additional Manufacturer Narrative
H3, h6: the device used in treatment was not returned for evaluation, all provided information has been reviewed and we have not been able to establish a relationship between the reported event or determine a root cause.The probable root causes are, application, removal, time left on patient, trauma, materials used within the dressing.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.No batch/lot number has been provided, therefore a review of the device history has not been possible.The complaint history file contains further instances.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: PRIMAPORE ADHESIVE 8X15CM CTN 20
• Common Device Name: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; hull east riding of yorkshire; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10948969
• Report Number: 8043484-2020-04024
• Device Sequence Number: 3084310
• Product Code: KXG
• UDI-Device Identifier: 05000223420253
• UDI-Public: 05000223420253
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 66000318
• Device Catalogue Number: 66000318
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 11/04/2020; 05/21/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 12/05/2020; 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other