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	Pain (1994); Blister (4537); Swelling/ Edema (4577)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier, age or date of birth, weight,ethnicity, race: not provided.No product lot number was provided and no sample was available.Without a lot number, expiration date and manufacture date could not be determined.A lot number was not provided.Without a lot number, no focused investigation of the batch record could be completed.A medical complaint history review was completed for 3m steri-strip¿ reinforced skin closures from march 1, 2020 to march 23, 2022.No trend was seen.Complaints will continue to be monitored.
Event or Problem Description
Received from (b)(6): an allergic reaction was alleged with use of 3m steri-strip adhesive skin closures that were applied post-surgically and covered with a dressing after a right total knee replacement.Nine strips were applied and removed when blister(s) developed.A pre-surgical alcohol body wash and a skin preparation with alcohol and chlorhexidine gluconate were applied.Four days after the surgery, the patient was transferred to a rehabilitation hospital, and drainage was observed around the dressing.The dressing was removed, and inflammation and swelling around the area was observed.The area was covered in betadine, a compression bandage was applied, and furosemide was prescribed along with antibiotics prophylactically.Iodine had been placed on the area and it was left open to the air after removal of the dressing ten days later.The skin fully healed.The patient was also seeing a physiotherapist.Due to the reaction with fluid around the knee, the patient alleged a setback with the rehabilitation that was planned and that there is less mobility in the knee.

• 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
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: dianne gibbs ; 3m center building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 13875168
• Report Number: 2110898-2022-00025
• Device Sequence Number: 4716567
• Product Code: KGX
• UDI-Device Identifier: 30707387023677
• UDI-Public: 30707387023677
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2022

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: R1541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALCOHOL BODY WASH; ALCOHOL PREP WITH CHLORHEXIDINE GLUCONATE; DRESSING (BRAND NAME UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female