MAUDE Adverse Event Report: 3M HEALTH CARE UNKNOWN; TAPE AND BANDAGE, ADHESIVE

Model Number N/A

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

Patient Problems Burn(s) (1757); Scar Tissue (2060)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

A sample was not available for analysis.Product catalog number, lot number and brand name are unknown.

Event Description

Burns and scarring of the cheeks underneath application areas of 3m tape were reported after a facial reconstruction surgery of the nose.The tape reported, 1-inch in size (brand name, catalog, and lot number unknown), was applied with a gauze (brand unknown).Burning the day of surgery underneath the tape and was reported to a physician; the tape was not removed and remained in place upon discharge.Application of other products during or after the surgical procedure is unknown.Subsequent hospitalization for observation was reported starting the next day for three days; no treatment was reported.It was reported that the surgeon was seen about three months later and no treatment was provided for the symptoms.

• Brand Name: UNKNOWN
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M BROOKINGS; 601 22nd avenue south; brookings SD 57006
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 14147235
• MDR Text Key: 289599224
• Report Number: 2110898-2022-00031
• Device Sequence Number: 1
• Product Code: KGX
• 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
• Type of Report: Initial
• Report Date: 04/19/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GAUZE
• Patient Outcome(s): Disability; Hospitalization
• Patient Sex: Male