MAUDE Adverse Event Report: 3M COMPANY 3M NEXCARE TEGADERM + PAD; DRESSING, WOUND, HYDROPHILIC

Catalog Number 3587

Device Problem Product Quality Problem (1506)

Patient Problems Discomfort (2330); Skin Inflammation/ Irritation (4545)

Event Date 10/29/2022

Event Type  malfunction  

Event Description

A few days ago, i had bought a 3 pack of nexcare tegaderm + pad from the grocery store.I bought this nexcare product because it appeared to be a good quality product used to cover surgical incisions and it states on the product's box that absorbent pad won't stick to the wound.This is completely untrue.I placed a nexcare tegaderm + pad on my inguinal hernia incision after a shower on friday (b)(6) 2022 and when i tried to remove it on saturday (b)(6) 2022 prior to another shower, i could not easily remove this bandage from my groin area.I had to soap the area and let water run over it for more than 20 minutes in order to remove this nexcare tegaderm + pad from my hernia incision.This should not have happened and it caused me great discomfort to remove this transparent dressing from my skin.It is as if 3m/ nexcare uses some type of super glue as the adhesive for this transparent dressing and this caused very much irritation to the incision area.I will also be filing this complaint with the us fda to advise them of my experience with this nexcare product as it is currently marketed as suitable for surgical incisions.This product can do more harm than good for any patients who use it to cover surgical wounds.If i had this problem when using this transparent dressing as directed, i am certain other consumers are experiencing similar issues as well.Fda safety report id# (b)(4).

• Brand Name: 3M NEXCARE TEGADERM + PAD
• Type of Device: DRESSING, WOUND, HYDROPHILIC
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 15715355
• MDR Text Key: 302936470
• Report Number: MW5113010
• Device Sequence Number: 1
• Product Code: NAC
• UDI-Device Identifier: 00707387435875
• UDI-Public: 0100707387435875
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 3587
• Device Lot Number: 33FENT
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White