MAUDE Adverse Event Report: SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LTD ADAPTIC NON-ADHERING DRESSING

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Tissue Damage (2104)

Event Date 10/31/2013

Event Type  Injury  

Event Description

On (b)(6) 2015, kci received the following information from the systagenix representative who conducted a post market surveillance internet search from the united states based website (b)(6): "it did adhere to the wound, ever so slightly.That's all it took to keep the wound from healing in the first place.I will not be using this product in the future as it stuck to the wound and caused me more pain than i thought it would.If it was truly non-adhering, it would have fallen off the second the wrap came off." no additional information is available.The contact information of the complainant was not provided.Therefore, kci is unable to make any further attempts to obtain additional information.

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged dressing adhering to wound, which caused pain and kept the wound from healing is related to the adaptic non-adhering dressing.It is unknown if medical or surgical intervention was required.

• Brand Name: ADAPTIC NON-ADHERING DRESSING
• Type of Device: ADAPTIC NON-ADHERING DRESSING
• Manufacturer (Section D): SYSTAGENIX WOUND MANAGEMENT MANUFACTURING LTD; gargrave, north yorkshire, england BD23 3RX; UK BD23 3RX
• Manufacturer Contact: paul arrendell ; 6203 farinon drive; san antonio, TX 78249 ; 2105154108
• MDR Report Key: 4886332
• MDR Text Key: 6062200
• Report Number: 3007663067-2015-00002
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2015
• 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): Other