MAUDE Adverse Event Report: ADHESIVE PAD; TAPE AND BANDAGE, ADHESIVE

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

Patient Problem Burn, Thermal (2530)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Pt reports mckesson adhesive pad burned and broke her skin.

• Brand Name: ADHESIVE PAD
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• MDR Report Key: 9632505
• MDR Text Key: 176684697
• Report Number: MW5092534
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/24/2020

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other