MAUDE Adverse Event Report: 3M HEALTH CARE NEXCARE TEGADERM TRANSPARENT DRESSING; TEGADERM¿ DRESSING

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity & race: information was not provided.Health professional; occupation: information was not provided.No sample has been received for analysis.The 2-year complaint history was reviewed for the product's global sales code (gsc) of szn and reported failure.No trends were observed.3m will continue to monitor.Testing confirms the biocompatibility of nexcare¿ tegaderm¿ transparent dressings for their intended use.In addition to performing clinical studies, 3m monitors its medical devices with manufacturing controls including in-process and release specifications/testing.Despite these studies and controls, there is a percentage of the population who are sensitive or who may become sensitive to adhesive products.
Event or Problem Description
The wife of a (b)(6)-year-old male consumer reported that she applied one of the larger-sized referenced dressings to cover a small cut on her husband's left forearm on approximately (b)(6) 2020.Prior to application, bacitracin was applied on the wound.The dressing was worn for five days.The dressing was removed on (b)(6) 2020.The wife alleged the dressing was very difficult to remove.The dressing was reportedly removed slowly while the wife held tight to her husband's skin.The wife alleged a layer of her husband's skin was ripped off during removal.The skin area reportedly bled.She alleged her hands were full of blood.The wife reported that her husband has thin skin.No known allergies or additional skin sensitivities were specified.A neighbor, rn by profession, applied a non-porous pad, 3" gauze and an elastic bandage on the skin area.The wife took her husband to urgent care to evaluate the area.The medical facility applied bacitracin on the wound and provided the husband with an unspecified antibiotic.The wife reported that her husband was taking the medication as prescribed and the skin area was healing.

• Brand Name: NEXCARE TEGADERM TRANSPARENT DRESSING
• Common Device Name: TEGADERM¿ DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul, mn
• MDR Report Key: 10162803
• Report Number: 2110898-2020-00032
• Device Sequence Number: 19700084
• Product Code: NAD
• UDI-Device Identifier: 00051131211834
• UDI-Public: 051131211834
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

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: Other
• Device Expiration Date: 07/05/2022
• Device Model Number: N/A
• Device Catalogue Number: TEGA-10
• Device Lot Number: 19283J
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/17/2020
• 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; Required Intervention
• Patient Age: 77 YR