MAUDE Adverse Event Report: CONVATEC INC. DUODERM® EXTRA THIN CGF® (CONTROL GEL FORMULA); DRESSING,WOUND,OCCLUSIVE

Model Number 187955

Device Problem Failure To Adhere Or Bond (1031)

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

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No additional patient/ event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).Note: this complaint issue occurred on (b)(4) separate cases.A separate 3500a form has been completed for the other (b)(4) cases.

Event Description

End user reports the dressing adhesive does not feel sticky which is resulting in the dressing falling off.He attempted to use the dressing anyway and it fell off in less than 1 (one) day.

Manufacturer Narrative

A batch record review indicates no discrepancies.Process checks and quality checks were performed with acceptable results.No additional action is required and this complaint will be closed.This issue will be monitored through the post market monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: DUODERM® EXTRA THIN CGF® (CONTROL GEL FORMULA)
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5841368
• MDR Text Key: 51002455
• Report Number: 1049092-2016-00354
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: 187955
• Device Lot Number: 6A02145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2016
• Initial Date FDA Received: 08/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 84 YR