MAUDE Adverse Event Report: CONVATEC LIMITED VERSIVA XC, ADHESIVE DRESSING, 14CM X 14CM; DRESSING,WOUND,HYDROPHILIC

Model Number 410610

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problems Pain (1994); Tissue Damage (2104)

Event Date 12/29/2011

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Complainant reported "a skin transplantation was carried out on my mother.The borrow area is located on the right thigh.Versiva xc was used in the hospital for wound treatment and it made good progress.On reorder-ing in the pharmacy, versiva (xc) was supplied.Unfortunately the effect is not the same: the newly created skin comes off again and again on dressing change (causing pains for my mother), although the dressing is moistened with (b)(4) already before.".

• Brand Name: VERSIVA XC, ADHESIVE DRESSING, 14CM X 14CM
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): CONVATEC LIMITED; first ave; deeside industrial park; deeside, flintshire CH52N U; UK CH52NU
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5289598
• MDR Text Key: 33280757
• Report Number: 1000317571-2015-40035
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Expiration Date: 03/01/2013
• Device Model Number: 410610
• Device Lot Number: 0C01720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2010
• 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