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 Erythema (1840); Inflammation (1932); Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

On march 20, 2021, a (b)(6) years old female customer used the tegaderm transparent dressing to cover a cut on her right forearm and bicep muscle.Prior to applying the transparent dressing, the wound was washed with peroxide, allowed to dry and neosporin was applied.He reported that the wound was bleeding slightly before the dressing was applied.On an unspecified date, he tried to remove the dressing.He alleged the dressing was difficult to remove.He tried to remove the dressing by applying peroxide and goo gone on the area.On (b)(6) 2021, he tried to remove the dressing by applying baby oil on the dressing, he tried applying ice on the dressing for 2 -3 minutes and he also tried applying a piece of tape on the edges of the dressing to pull off the dressing.He alleged all methods were unsuccessful.He changes the dressing every 4 days, but the dressing was on for 8 days or 9 days.He alleged that the skin under the bandage was raw from trying to get the dressing off.He alleged that the area is uncomfortable, and his wife can't sleep.On (b)(6) 2021, the doctor at an urgent care center tried to remove the tegaderm dressing by putting a thin slice in the dressing and then pulling it up.The doctor was unable to remove the dressing because her skin was pulling with the dressing.The doctor told them they will need to go to the hospital, and have the dressing burned off as it is now part of her skin.The doctor gave them a coloplast product (type unspecified) to apply on the area.He alleged the area is getting infected.On (b)(6), 2021, they used alcohol pads and a paper towel soaked in vodka to wipe down the edge of the dressing.They alleged that the method was painful, and her skin turned red, so they stopped.On thursday (b)(6) 2021, the tegaderm dressing was removed at a wound center.The customer alleged the wound nurse stated the wound was bad and they will need to follow up every two weeks for at least two months.Before they went to the wound center, they already started applying triple antibiotic cream on the area and the dressing was starting to come off.After the tegaderm dressing was removed, they covered the wound with zinc pad.The customer is allergic to codeine.No medical history 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: 11713041
• MDR Text Key: 247254475
• Report Number: 2110898-2021-00022
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/12/2023
• Device Model Number: N/A
• Device Catalogue Number: H1624
• Device Lot Number: 20272J
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• 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): Other; Required Intervention
• Patient Age: 78 YR