MAUDE Adverse Event Report: 3M COMPANY 3M NEXCARE SOFT N' FLEX; BANDAGE, ELASTIC

Model Number SOFT N' FLEX NATURAL FEEL BANDAGES

Device Problem Material Integrity Problem (2978)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 07/16/2018

Event Type  No Answer Provided  

Event Description

I recently had shoulder surgery and after i was able to remove and replace the bandages.I purchased "3m nexcare soft 'n flex 2"x4" bandages" to cover the wound.I used them for 5 days, replacing them each morning.On (b)(6) 2018, i was removing the band-aid and the bandaged also removed the 1st layer of my skin, by approx 1 x 1 inch square.It immediately started bleeding and is extremely painful.Retailer: (b)(6).Retailer state: (b)(6).Purchase date: (b)(6) 2018.Document number: (b)(4).Report number: (b)(4).

• Brand Name: 3M NEXCARE SOFT N' FLEX
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 7801563
• MDR Text Key: 117900273
• Report Number: MW5079247
• Device Sequence Number: 0
• Product Code: FQM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Device Operator: No Information
• Device Model Number: SOFT N' FLEX NATURAL FEEL BANDAGES
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR