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

Model Number	66020796
Medical Device Problem Codes	Device Emits Odor (1425); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Disorders (4543)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It as reported that during therapy using a renasys f device patient stated that odor was coming from his wound, the nurse came out three time a week but the smell is repulsive even thought she changed the dressing.Wound is to the chest and from a biopsy that became infected.It is uncertain if this odor was caused by the renasys, the dressing or the size.Patient's status is unknown and no further information is available.
Additional 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 product and reported event, or determine a root cause.Probable root cause of the reported odour may be odour-causing bacteria present in the patient's infected wound.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture, the reported file is held by the quality release team.A complaint history review found further instances of the reported events.The instructions for use has been reviewed and contains comprehensive instructions on the safe operation and use 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.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.An odor in the device would not be likely to cause or contribute to a death or serious injury.Event may require use of a backup device to continue therapy.This event did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.This event is considered not reportable pursuant to 21 cfr §803.

• Brand Name: RENASYS F LARGE 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: 12442622
• Report Number: 8043484-2021-01738
• Device Sequence Number: 17347224
• Product Code: OMP
• UDI-Device Identifier: 00040565127187
• UDI-Public: 00040565127187
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K142979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/29/2022
• Device Model Number: 66020796
• Device Catalogue Number: 66020796
• Device Lot Number: 50902882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 10/26/2021; 10/26/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 10/27/2021; 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male