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

Catalog Number 66800795

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Blister (4537); Skin Infection (4544); Contact Dermatitis (4546)

Event Date 06/28/2021

Event Type  Injury  

Event Description

It was reported that, after npwt treatment with renasys f medium w/soft port had been performed daily, since (b)(6) 2021, the patient experienced an allergic reaction and blisters, 3 days later.This adverse event was treated on (b)(6) 2021 with antibiotics, and npwt was stopped.Current health status of patient is unknown.

Event Description

It was reported that, after npwt treatment with renasys f medium w/soft port had been performed daily since (b)(6) 2021, the patient experienced an allergic reaction and blisters, 3 days later.This patient was treated on (b)(6) 2021 with antibiotics and npwt was stopped.Current health status of patient is unknown.

Manufacturer Narrative

H10: 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.Probable root cause includes application technique, including sensitivity to topical agents used with the dressing.No lot/serial number has been provided, therefore a review of the device history record is not possible.A complaint history review was performed for the product and failure mode reported and there have been further instances.The ifu 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.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.B5: updated description.H6: updated codes.

• Brand Name: RENASYS F MEDIUM W/SOFT PORT
• Type of Device: 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: 12242902
• MDR Text Key: 264053518
• Report Number: 8043484-2021-01650
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 40565125923
• UDI-Public: 40565125923
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800795
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention