MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ STERI-STRIP¿ BLEND TONE 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 Code	Rash (2033)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information: information was not provided.Date of event: specific date of occurrence was not provided.The customer reported the patient rashes occurred within the last month.Lot #: the product lot number for the steri-strip blend tone skin closures applied to the patients who experienced a rash was unknown.The customer reported 2023-07au was the current lot number in stock.A medical complaint history review was completed for steri-strip skin closures from (b)(6) 2017 - (b)(6) 2019.The number of medical complaints were low with no trends noted.Complaints will continue to be monitored.
Event or Problem Description
A customer alleged b1557 3m¿ steri-strip¿ blend tone skin closures were applied to plastic surgery patients in the operating room.The customer alleged three to four patients experienced a rash with use of the steri-strip closures.The customer estimated three of the four patients experienced a significant skin rash requiring treatment with a steroid dose pack.Individual patient information was not provided.The customer reported all of the patient rashes were resolved.

• Brand Name: 3M¿ STERI-STRIP¿ BLEND TONE 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: 8427833
• Report Number: 2110898-2019-00038
• Device Sequence Number: 2639752
• Product Code: KGX
• UDI-Device Identifier: 30707387416837
• UDI-Public: 30707387416837
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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: B1557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/18/2019
• 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