MAUDE Adverse Event Report: CONVATEC, INC. DUODERM EXTRA THIN CGF DRESSING; DRESSING,WOUND,OCCLUSIVE

Lot Number 7H06247 2022-08

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 01/10/2018

Event Type  malfunction  

Event Description

Per nursing leader, duoderm noted not to be sticking.

Event Description

Per nursing leader, duoderm noted not to be sticking.

• Brand Name: DUODERM EXTRA THIN CGF DRESSING
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CONVATEC, INC.; 200 headquarters park dr; skillman NJ 08558
• MDR Report Key: 7221111
• MDR Text Key: 98313172
• Report Number: 7221111
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: 7H06247 2022-08
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.