MAUDE Adverse Event Report: 3M BROOKINGS 3M¿ COBAN¿ NL NON-LATEX SELF-ADHERENT WRAP; PRESSURE BANDAGE, NON-LATEX

Catalog Number	2083-1X
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Erythema (1840); Itching Sensation (1943); Blister (4537)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1, a2 & a4-a6: not provided.H10: product sample was not returned to 3m for analysis.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to definitively determine the root cause.The instructions for use states: warnings.Coban nl self-adherent wrap will not slip or loosen after application.Do not wrap too tightly to avoid impairing circulation and causing serious injury.Monitor area frequently (no less than every 24 hours) for signs of swelling, discoloration, pain, numbness, tingling, or other changes in sensation.If these symptoms occur, remove wrap immediately and contact your health care provider.Precautions.1.When used as a component in a compression wrap system, it is important to ensure adequate arterial blood flow to avoid injury secondary to decreased circulation.Coban nl self-adherent wrap should be used as a component of a compression wrap system only under the supervision of a wound carespecialist.2.Do not reuse a piece that has already been used as it may impact product performance.3.This product is intended for a one-time use on a single patient to reduce the risk of cross-contamination from the wrap between patients.4.Due to the construction of 3m¿ coban¿ nl non-latex self-adherent wrap and the potential for compromised performance that could impact efficacy of the therapy, it is not recommended for use with zinc oxide paste applications associated with the treatment of venous leg ulcers.Consider the use of a multilayer compression system such as 3m¿ coban¿ 2 two-layer compression system or 3m¿ coban¿ 2 lite two-layer compression system for therapeutic compression needs.
Event or Problem Description
A male customer allegedly experienced a left arm itching/burning sensation, erythema, bumps, blistering approximately 1/8" with swelling thirty minutes post application of 3m¿ coban¿ nl non-latex self-adherent wrap, 2083-1x, lot# 3mpmdj.The physician administered an antihistamine (name unknown) and prescribed triamcinolone acetonide 0.1% cream.Most of the symptoms have reportedly resolved although the area is still red, and the customer continues to apply the topical cream.The customer reportedly has no history of allergies to tapes or other dressings, and confirmed there is no infection present.
Event or Problem Description
A male customer allegedly experienced a left arm itching/burning sensation, erythema, bumps, blistering approximately 1/8" with swelling thirty minutes post application of 3m¿ coban¿ nl non-latex self-adherent wrap, 2083-1x, lot# 33pmdj.
Additional Manufacturer Narrative
B5: lot number was corrected to 33pmdj.H10: a review of the batch data was performed and did not indicate any failures or non-conforming notifications during the manufacturing process.All of the testing met specifications.3m received a customer sample; however, due to the small size of the sampled provided, it was not a sufficient size in order to perform testing.Without a viable sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to definitively determine the root cause.

• Brand Name: 3M¿ COBAN¿ NL NON-LATEX SELF-ADHERENT WRAP
• Common Device Name: PRESSURE BANDAGE, NON-LATEX
• Manufacturer (Section D): 3M BROOKINGS; 601 22nd ave south; po box 5227; brookings SD 57006
• Manufacturer (Section G): 3M BROOKINGS; 601 22nd ave south; po box 5227; brookings SD 57006
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 17645042
• Report Number: 2110898-2023-00075
• Device Sequence Number: 15349802
• Product Code: FQM
• UDI-Device Identifier: 00707387802325
• UDI-Public: 00707387802325
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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 Expiration Date: 05/29/2026
• Device Catalogue Number: 2083-1X
• Device Lot Number: 33PMDJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male