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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Fungal Infection (2419); Blister (4537)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

The lot number of the 3m medipore surgical tape used was not provided and no samples were available for return for analysis.The blisters appeared to follow the longitudinal tract of an iv which may have infiltrated and does not appear to be causally related to the product.

Event Description

Report received from the fda via medwatch form mw5101440).A patient who was in the intensive care unit for 3.5 weeks followed by surgery for injuries sustained while in an accident developed deep blisters on both hands where iv and art lines were inserted that were secured with 3m medipore surgical tape.The blisters formed before surgery while in the icu; the left was deeper than the right; the left tunneled from the back of the hand to towards the thumb with fluid present.A nurse changed to application of a transparent dressing (brand name unknown) instead of the tape when the blisters were observed.After discharge, a physician's assistant recommended application of metahoney to the sores with bandaging and oral doxycycline was prescribed.The blisters on the right hand healed.After cultures were taken of the wounds on the left hand, clindamycin, oral was then prescribed.At a subsequent appointment with a physician, doxycycline was again prescribed along with application of bactroban.After wound surgeon referral, the bottom of the wounds of the left hand were scraped weekly and applications of metahoney resumed.After a few weeks of treatment, the patient was instructed to apply batroban.The sores on the left hand have reduced in size.

• Brand Name: 3M MEDIPORE 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 BROOKINGS; 601 22nd avenue south; brookings SD 57006
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 12186047
• MDR Text Key: 262163346
• Report Number: 2110898-2021-00040
• Device Sequence Number: 1
• Product Code: KGX
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/16/2021

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 Model Number: N/A
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 07/16/2021
• 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: 70 YR