MAUDE Adverse Event Report: 3M HEALTH CARE 3M STERI-STRIP REINFORCED SKIN CLOSURES; STERI-STRIP SKIN CLOSURES

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rash (2033); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no evidence supporting contributory causation to hypopigmentation by the 3m steri-strip reinforced adhesive skin closure.A sample was not available for return and a lot number was not provided.A medical complaint history review was completed for 3m steri-strip reinforced adhesive skin closures from april 1, 2019 - april 30, 2021.No trend was observed.Complaints will continue to be monitored.End of report.
Event or Problem Description
A rash with hives and itchiness and skin hypopigmentation was reported at the incision site on a rib where one 3m¿ steri-strip¿ reinforced adhesive skin closure was applied after a rhinoplasty was performed.The symptoms were observed about one week after the surgery, and betamethasone 0.1% ointment was prescribed and applied three times a day for four days.The symptoms resolved except for the hypopigmented area.The surgical incision is healing.

• Brand Name: 3M STERI-STRIP REINFORCED SKIN CLOSURES
• Common Device Name: STERI-STRIP SKIN CLOSURES
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 11810264
• Report Number: 2110898-2021-00030
• Device Sequence Number: 16931127
• Product Code: KGX
• UDI-Device Identifier: 30707387023646
• UDI-Public: 30707387023646
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: R1547
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR