MAUDE Adverse Event Report: ASO LLC CAREPAK; TAPE AND BANDAGE, ADHESIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Skin Tears (2516)

Event Type  Injury  

Event Description

Used the brand carepak bandaids to cover his stitches and it literally ripped the skin of my son's face.It wasn't even on for that long but it took the skin right off causing him to bleed.To cover his stitches.

• Brand Name: CAREPAK
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): ASO LLC
• MDR Report Key: 15970355
• MDR Text Key: 305498325
• Report Number: MW5113744
• Device Sequence Number: 1
• Product Code: KGX
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 12/08/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White