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

Model Number N/A

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

Patient Problems Local Reaction (2035); Unspecified Eye / Vision Problem (4471); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)

Event Date 12/02/2021

Event Type  Injury  

Manufacturer Narrative

Patient identifier -age or date of birth, weight-race: information not provided.Lot number was not provided; therefore, unable to determine expiration date and date of manufacture.A sample was not available for return for analysis and no lot number was provided.3m will continue to monitor.

Event Description

Burning sensation and itchiness of the eye lids, watery eyes, and blisters on the facial skin under the eyes were reported that occurred after the eye lids were taped with 3m transpore surgical tape and 3m micropore surgical tape during a shoulder surgery.Treatment included ice packs and a swab of unspecified topical cream or ointment applied to the affected facial skin areas.3m micropore tape was also applied at home after surgery and application was stopped when skin redness began at the application site.Tacrolimus ointment, 0.1 percent, applied twice daily was prescribed by a dermatologist and the symptoms improved.

• Brand Name: 3M TRANSPORE SURGICAL TAPE
• 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; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 13021643
• MDR Text Key: 282379640
• Report Number: 2110898-2021-00075
• 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: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• 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: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female