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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)

Event Date 09/06/2021

Event Type  Injury  

Manufacturer Narrative

Patient information: 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, a percent of the population is sensitive to adhesive products.End of report.

Event Description

A female customer (age unspecified) reported an incident regarding the nexcare¿ tegaderm¿ transparent dressing.On an unspecified date, she fell in her backyard.On (b)(6) 2021, per her doctor's recommendation, the tegaderm¿ transparent dressing was applied to her bilateral legs (exact location was unspecified) and her right upper arm covering the skin tears/scrapes she got from the fall.She reported that a nurse cleansed the wound with an unspecified antiseptic before the dressing was placed.She changed the dressing on (b)(6) 2021.On an unspecified date, she allegedly noticed black, white and green bubbles under the dressing.On (b)(6) 2021, the wound was cultured and dressed differently (details were not provided).She went back to the doctor on (b)(6) 2021.The doctor allegedly noticed a colorless drainage with slight odor draining from all three areas where the bandage was applied.The doctor took culture, cleansed each wound (details were not provided), applied an antiseptic pad and the covered with gauze.The doctor also prescribed her cephalexin antibiotics.The doctor notified a home health agency wound specialist to help with dressing change in her home.As of (b)(6) 2021, she is still taking the antibiotics.However, the alleged injury is resolving.No allergies, medical history or intervention reported.

• Brand Name: NEXCARE TEGADERM WATERPROOF TRANSPARENT DRESSING
• Type of Device: TEGADERM¿ DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 12583603
• MDR Text Key: 274967493
• Report Number: 2110898-2021-00062
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 00051137641143
• UDI-Public: 051137641143
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: H1626
• Device Lot Number: 21193J
• Date Manufacturer Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention