MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS F SMALL W/SOFT PORT; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66800794

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the black foam used for npwt was leaving a significant amount of fragments behind in the wound bed.The black foam is cut away from the wound to avoid fragments dropping into the bed yet the foam is leaving fragments behind upon dressing change.

Manufacturer Narrative

H3, h6: the device used in treatment was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.A probable root cause may include incorrect method used.Medical review concluded, the negative pressure wound therapy clinical guidelines also note to ¿rub the edges of the foam after cutting to remove any loose fragments.¿ based cytotoxicity testing the black foam passed cytotoxicity testing and is considered non-toxic.The patient impact beyond local irritation/discomfort, and/or migration cannot be determined.No further clinical/medical assessment is needed.Risk management file requires no update the instructions for use provide comprehensive instructions of the operation, use and limitations of the device.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: RENASYS F SMALL W/SOFT PORT
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11167291
• MDR Text Key: 226764378
• Report Number: 8043484-2021-00104
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 40565125916
• UDI-Public: 40565125916
• Combination Product (y/n): N
• PMA/PMN Number: K082211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800794
• Device Lot Number: 2019101332
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention