MAUDE Adverse Event Report: 3M HEALTH CARE 3M COBAN SELF ADHERENT WRAP; COBAN WRAP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Anaphylactic Shock (1703); Reaction (2414); Partial thickness (Second Degree) Burn (2694)

Event Date 12/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer reported a coban wrap was applied to her arm following a blood draw in an er.Customer did not have product catalog number or lot number.Customer reported she had a known latex allergy.The 3m medical complaint investigator attempted to identify the product that was applied.Based on the investigation, the facility appeared to have both 3m¿coban¿ wrap and 3m¿coban¿ lf wrap available for ordering.The 3m coban self adherent wrap contains the following information on the instructions for use (ifu): caution this product contains natural rubber latex which may cause allergic reactions.The ifu also contains a symbol noting the following explanation: explanation of symbols caution: this product contains natural rubber latex which may cause allergic reactions.

Event Description

Customer reported she was seen in a hospital emergency room (er) due to a rash that had intensified.While in the er, she reportedly had a coban wrap (unknown catalog number) applied to secure a cotton ball following a blood draw.Customer allegedly experienced a severe reaction described as 2nd degree latex burns on skin exposed to the area where the product had been applied.She reported the area became infected, painful and she was seen in the er.She reportedly received iv medication while in the er and received a rx for silver sulfadiazine cream.She reportedly had two subsequent anaphylactic reactions that reportedly may have been triggered by multiple factors including: combination of latex allergy dermal burns, allergy to prescriptions, food allergies, and dehydration.Customer reported she has a known latex allergy and multiple food allergies.Customer reported the burns have now healed following two solid weeks of treatment.

• Brand Name: 3M COBAN SELF ADHERENT WRAP
• Type of Device: COBAN WRAP
• 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: karen krenik ; 3m center; building 275-5w-06; st. paul, MN 55144 ; 6517333091
• MDR Report Key: 6396605
• MDR Text Key: 69635997
• Report Number: 2110898-2017-00028
• Device Sequence Number: 1
• Product Code: FQM
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2017
• 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): Life Threatening; Required Intervention