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

Model Number 412020

Device Problem Increased Sensitivity (2535)

Patient Problems Inflammation (1932); Itching Sensation (1943); Local Reaction (2035)

Event Date 05/06/2014

Event Type  Injury  

Event Description

It is reported that patient underwent left total knee replacement, on day two (2) post operatively aquacel surgical cover dressing was removed due to clinical need as exudates levels dictated and no issues were identified.As per local policy a second aquacel surgical dressing was applied and left in place until clips were due to be removed ((b)(6) 2014), the patient reported severe itching for two days prior to removal of the dressing.Upon removal of the dressing the "whole area under the adhesive was bright red, slightly raised and itchy".Treatment provided with piriton tablets and hydrocortisone cream.It is also reported that the product was in use for nine (9) days before the event occurred.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury based on the report that patient was treated with piriton tablets and hydrocortisone cream.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.Convatec will continue to track and monitor such complaints according to convatec inc's complaint handling and capa procedures.

• Brand Name: AQUACEL/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: 3879486
• MDR Text Key: 4568919
• Report Number: 1049092-2014-00160
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 412020
• Device Catalogue Number: 41202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2014
• 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