MAUDE Adverse Event Report: 3M CANADA COMPANY 3M¿ COBAN¿ SELF-ADHERENT WRAP WITH LATEX; BANDAGE, ELASTIC

Catalog Number 1582

Device Problem Human-Device Interface Problem (2949)

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033)

Event Date 05/06/2023

Event Type  Injury  

Manufacturer Narrative

A1-a6: not provided.E2-e3: it is unknown if the reporter is a health professional.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 the following: caution: this product may contain natural rubber latex which may cause allergic reactions.Warnings: 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.Do not place coban self-adherent wrap in direct contact with an open wound because it may lead to infection.Precautions: 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 self-adherent wrap should be used as a component of a compression wrap system only under the supervision of a wound care specialist.Do not reuse a piece that has already been used as it may impact product performance.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.

Event Description

A patient allegedly experienced a localized rash, itching sensation and discomfort three days post application of 3m¿ coban¿ self-adherent wrap with latex, 1582 lot 104458892 with medical tape.The patient reported the symptoms, and the nurse "suspected that the tape was allergic." the doctor subsequently determined the wrap was allergic.The indwelling needle was replaced, fixed with dressing, and prescribed mupirocin ointment was applied locally for anti-allergy.Upon hospital discharge, two days post reaction, the patient's skin recovered.

• Brand Name: 3M¿ COBAN¿ SELF-ADHERENT WRAP WITH LATEX
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): 3M CANADA COMPANY; 400 route 100; morden, manitoba R6M 1 Z9; CA R6M 1Z9
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH; werk kamen; edisonstrasse 6; kamen, 59174 ; GM 59174
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 17750116
• MDR Text Key: 323472006
• Report Number: 2110898-2023-00074
• Device Sequence Number: 1
• Product Code: FQM
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1582
• Device Lot Number: 104458892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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