MAUDE Adverse Event Report: CONVATEC, INC. AQUACEL AG - SURGICAL COVER DRESSINGS; DRESSING, WOUND, DRUG

Model Number 420669

Device Problems Sticking (1597); Suction Problem (2170)

Patient Problems Skin Discoloration (2074); Skin Inflammation (2443); Skin Tears (2516)

Event Date 04/07/2014

Event Type  Injury  

Event Description

It is reported that physician saw the patient at her six week post operative review who complained that when the district nurse removed the dressing related to the posterolateral hip (dressing same and size not stated at this stage) it had stuck and some blistered skin came off with the dressing.The patient also indicated that the skin around the wound was bright red like a "chemical burn" and that "all the area of discoloration was red." the affected site was treated with dressing changes (type unk) by the district nurse until it healed.Additional information received via email on (b)(6) 2014 states the following: the product was in use for 15 days before event occurred and that the product size was "long-ref 420 669 9x30cm, small-ref 412 019 9x25cm.".

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.It is reported that the district nurse dressed affected site until healed.Please note: this case is related to patient identifier#" (b)(6); mfr report#: 1049092-2014-00167.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.(b)(4).Convatec will continue to track and monitor such complaints according to convatec inc's.Complaint handling and capa procedures.

• Brand Name: AQUACEL AG - SURGICAL COVER DRESSINGS
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, associate dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3888030
• MDR Text Key: 4653888
• Report Number: 1049092-2014-00166
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K091034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 420669
• Device Catalogue Number: 420669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention