MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS; DRESSING,WOUND,HYDROPHILIC

Model Number 420669

Device Problem Difficult to Remove (1528)

Patient Problems Tissue Damage (2104); Discharge (2225)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.No lot number is available.A detailed investigation or batch review cannot be conducted.Although a photograph (s) has been received, no evaluation will be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that one week after a left knee operation, the plaster (dressing) was gently removed by the end user and pale liquid was oozing and running down end user¿s leg.End user states the dressing was very difficult to remove and she had to support the skin to stop it from tearing.Two small blisters were present under the dressing and the wound was wet.End user states it took three visits back to the hospital for treatment to the blistered area which after eight weeks is almost back to normal.Photos depicting the reported complaint issue were provided by the complainant.

• Brand Name: AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409
• MDR Report Key: 7915787
• MDR Text Key: 122163032
• Report Number: 9618003-2018-01560
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 420669
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2018
• 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: N
• Patient Sequence Number: 1