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.Based on the available information, no patient harm occurred.No additional patient/ event details have been provided to date.Should additional information become available, a follow-up report will be submitted.Note: (b)(4) cases are associated with this complaint.Separate 3500a forms have been completed to for the other cases.(b)(4).

Event Description

End user applies the product to bilateral hips to prevent pressure ulcers.Normal wear time of product is 3 days but product from this box does not adhere to skin.No further information was provided.

Manufacturer Narrative

A batch record review was performed on the finished lot and all sub-assemblies associated with lot # 5e01364.The batch record review indicated a discrepancy with one mix lots used to produce the product.The discrepancy had no impact on this reported event, as the suspect material was identified, quarantined and destroyed.There were no other discrepancies.The sterilization certificate was reviewed and concluded that the associated lot was sterilized according to procedure.Process checks were performed.No further action is required and this complaint will be closed.This issue will be monitored through the post market product 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: 5695929
• MDR Text Key: 46467567
• Report Number: 1049092-2016-00260
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K891696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 05/11/2016

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: 04/30/2017
• Device Model Number: 187955
• Device Lot Number: 5E01364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 06/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2015
• 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: 80 YR