MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ DURAPORE¿ SURGICAL TAPE; TAPE AND BANDAGE, ADHESIVE

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Ulcer (2274); Blister (4537)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifier, weight: not provided.A sample was not available for return for analysis and a lot number was not provided.Based on this complaint report provided by the hospital personnel, causality is indeterminate, and as stated by the initial reporter could be due to the patient's own reasons.

Event Description

Received from (b)(6): a dressing was affixed with durapore surgical tape to protect an incision and skin blisters (1 × 1.5cm) with ulceration developed two days later in two places in the tape on the left shoulder and under the xiphoid process.The area was disinfected, covered with a sterile dressing, replaced with 3m elastic tape, and cefuroxime axetil tablets, 250mg twice a day, were provided to prevent infection.

• Brand Name: 3M¿ DURAPORE¿ SURGICAL TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH, WERK; manufacturing medical devices; edisonstrasse 6; kamen, 59174 ; GM 59174
• Manufacturer Contact: dianne gibbs ; 3m center building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 13573656
• MDR Text Key: 286153457
• Report Number: 2110898-2022-00019
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian