MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ STERI-STRIP¿ COMPOUND BENZOIN TINCTURE

Catalog Number	C1544
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Rash (2033)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In the absence of a lot / batch number, no focused investigation of manufacturing batch records can be reasonably completed.In the absence of a sample, the problem, product adherence to specifications, and root cause could not be verified because neither functional nor chemical tests could be performed.A general review of complaints from march 2017 to march 2019 was completed for this complaint and no trend was noted with the data.The consumer reported 3m¿ steri-strip¿ compound benzoin tincture and 3m¿ r1547 reinforced steri-strip¿ skin closures were applied following his surgery.2110898-2019-00049 was submitted for 3m¿ r1547 reinforced steri-strip¿ skin closures.2110898-2019-00050 was submitted for 3m¿ steri-strip¿ compound benzoin tincture.End of report.
Event or Problem Description
A consumer reported 3m¿ steri-strip¿ compound benzoin tincture and 3m¿ r1547 reinforced steri-strip¿ skin closures were applied to seven puncture sites on his leg following varicose vein surgery.One week following the surgery he had a follow-up appointment and redness was noted at all seven sites.He was reportedly given a rx for triamcinolone acetonide cream for treatment.He used the cream for three days and reportedly broke out in a body rash.He was seen by his surgeon and the triamcinolone acetonide cream was discontinued.His surgeon prescribed oral methylprednisolone.The consumer reportedly took the methylprednisolone for three days and went to the er due to frequent urination.The methylprednisolone was discontinued.The consumer consulted an allergist the following day due to the unresolved body rash and was diagnosed with contact dermatitis.He was reportedly treated with an unspecified rx cream.

• Brand Name: 3M¿ STERI-STRIP¿ COMPOUND BENZOIN TINCTURE
• Common Device Name: COMPOUND BENZOIN TINCTURE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 8518797
• Report Number: 2110898-2019-00050
• Device Sequence Number: 16512619
• Product Code: KGX
• UDI-Device Identifier: 30707387022830
• UDI-Public: 30707387022830
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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 Catalogue Number: C1544
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: R1547 REINFORCED STERI-STRIP¿ SKIN CLOSURES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR