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

Model Number	66801280
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Swelling/ Edema (4577)
Date of Event	01/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that, during npwt for a dehisced tummy tuck incision, utilizing a renasys f medium w/soft port, the patient mentioned that the area around the hips was a bit swollen, but the wound was feeling fine and was draining well.It was stated that the swelling the patient had mentioned was independent of the npwt and more a result of how the skin had settled after the operation.It was a cosmetic issue rather than anything else.Treatment is being performed, without any delay, with the same device.Additionally, it was reported that the wound was swabbed and detected presence of bacteria so the patient commenced with an antibiotic treatment.
Additional Manufacturer Narrative
The device was not returned for evaluation.All supplied information has been reviewed and we have not been able to confirm the complaint or determine a root cause for the reported event.Medical review concluded, this case reports swelling following a tummy tuck procedure.The occurrence of swelling is a known complication of any surgery and is not presumed to be related to the use of the renasys device.Per e-mail communication, ¿wound was swabbed, and detected presence of bacteria so commenced on an antibiotic but that this wasn¿t related to the initial complaint of swelling on the side.¿ treatment was continued with the same renasys npwt device.No further clinical/medical assessment is warranted at this time.A documentation review has been conducted, confirming no previous complaints of this nature, with no historical escalations or manufacturing problems observed.A review of the device history confirmed that no manufacturing problems where observed.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files do not address the reported harm of swelling/edema as it is a common post-operative complication that is unrelated to the device or its use.Local infection is documented appropriately within the risk file and no updates are required at this time.While a definitive root cause for the reported issues could not be determined, swelling/edema is a common post-surgical complication and is not presumed to be related to the use of the device.Additionally, we are unable to rule out user/procedural variance as a contributing factor to the reported bacterial infection of the wound.The ifu includes instructions to ¿carefully and frequently monitor the patient, device, and dressing to determine if there are any signs of bleeding, exudate accumulation (pooling), infection, maceration, or loss of negative pressure wound therapy.¿ the frequency of monitoring and dressing changes should be determined by the clinician based on individual characteristics of the patient and wound.With no manufacturing quality concerns observed, no corrective actions are deemed necessary.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.

• Brand Name: RENASYS F MEDIUM W/SOFT PORT
• Common Device Name: 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13365347
• Report Number: 8043484-2022-00033
• Device Sequence Number: 5185466
• Product Code: OMP
• UDI-Device Identifier: 00040565126586
• UDI-Public: 00040565126586
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 66801280
• Device Catalogue Number: 66800795
• Device Lot Number: 63039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 04/15/2022
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTIBIOTICS
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female