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 11/18/2020

Event Type  Injury  

Manufacturer Narrative

Reference: (b)(4).

Event Description

It was reported that community nurse has reported that she has now seen 4 separate patients, each with what appears to be foam granules in the base of their wounds.Procedure was completed with a competitor device no harm or injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device intended for use 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.No lot/serial number has been provided; therefore a review is not possible.A complaint history review found further instances of the reported event.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional risk management review is not required.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 east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11243209
• MDR Text Key: 229098819
• Report Number: 8043484-2021-00189
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 40565125916
• UDI-Public: 40565125916
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800794
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention