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PRIMAPORE ADHESIVE DRESSING 15*8CM 66000318Recalls & reported problems

Smith & Nephew Medical Limited · Non-woven adhesive wound dressing · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05000223420253), received between Dec 4, 2020 and Dec 4, 2020 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Local Reaction1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    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.

    Patient problems: Local Reaction

    MAUDE report 10948969 ↗

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Sources and updates

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