MAUDE Adverse Event Report: 3M HEALTH CARE TEGADERM TRANSPARENT FILM DRESSING; DRESSING, WOUND, DRUG

Device Problems Sticking (1597); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2018

Event Type  malfunction  

Event Description

Tegaderm bandages are not opening correctly.When top layer of dressing wrapper is pulled back, the tegaderm is not pulling with it.Instead, it is sticking to the underside of the wrapper.It was first noticed while preparing for dressing change.A replacement was gathered and it too had a problem.Several of the bandages from the box were noted to have the same issue.A sample was turned in to this reporter for return to the mfr.This did not reach the pt to cause harm, a different dressing was utilized.

• Brand Name: TEGADERM TRANSPARENT FILM DRESSING
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): 3M HEALTH CARE; st paul MN 55144
• MDR Report Key: 7214854
• MDR Text Key: 98235232
• Report Number: MW5074754
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 DA