MAUDE Adverse Event Report: 3M HEALTH CARE 3M STERI-STRIP ELASTIC SKIN CLOSURES; TAPE AND BANDAGE, ADHESIVE

Model Number N/A

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

Patient Problems Edema (1820); Erythema (1840); Itching Sensation (1943); Rash (2033); Skin Discoloration (2074)

Event Date 06/21/2015

Event Type  Injury  

Manufacturer Narrative

Patient information: information was not provided.Product catalog and lot number were not provided.Without a catalog and lot number, expiration date, manufacture date and udi cannot be determined.A medical complaint history review was completed for the entire 3m¿ steri-strip¿ adhesive closure product line from july 1, 2018 - july 28, 2020.No adverse trend was observed.Complaints will continue to be monitored.

Event Description

A female consumer, who is also an m.D., reported an allergic contact dermatitis allegedly with use of 3m¿ steri-strip¿ skin closures (product type and catalog number unknown) placed one day after a left hip arthroplasty was performed.A topical skin adhesive was used for wound closure and a sterile dressing was applied, followed by application of liquid adhesive and steri-strips¿ the next day.Six days post-surgery, pruritis, erythema, edema extended an estimated 4cm around the incision site and blisters developed in the location of the skin closure strips.The skin closure strips were removed eight days after application.Two days later, the symptoms extended over the hip and lateral thigh.The symptoms progressed to a maculopapular rash from the face to the ankles, and oral prednisone was prescribed (60mg/day for 2-4 days, followed by a dose reduction to an estimated 20mg per day for the next 2-4 days).The blisters, erythema and rash resolved within a few days; a recurrent erythematous rash with mild pruritus under areas of tight clothing persisted for a few weeks, and purple-colored, lichenified skin surrounding the incision returned to normal after 2-3 months.Steri-strip¿ adhesive skin closures (product name and catalog number unknown) and the same brands of topical skin adhesive and liquid adhesive were applied for a prior hip arthroplasty and no adverse symptoms occurred.

• Brand Name: 3M STERI-STRIP ELASTIC SKIN CLOSURES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul, mn
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings, sd
• Manufacturer Contact: dianne gibbs ; 3m center building 275-5w-06; st. paul, mn ; 7379117
• MDR Report Key: 10397324
• MDR Text Key: 202673196
• Report Number: 2110898-2020-00037
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention