MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS GO; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 66021496

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Skin Disorders (4543)

Event Date 01/19/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that a patient had been using renasys go for approximately 3 weeks without any notable issue, then when a health care professional visited the patient discovered that there was blood all over the foot therefore decided to stop the use of the device because patient's foot was very macerated.Patient states that the device did not preset any warning signs.Wound is currently being treated with a cream and a wet-to-dry dressing.No other complications were reported.No further information is available.

Manufacturer Narrative

H3, h6: the investigation into the reported event is now complete, the returned device has been evaluated, with no faults found the reported event cannot be confirmed.A visual inspection noted no obvious defects, the functional evaluation found no device faults, odor was present, although this is normal and deemed to be general wear from use.A documentation review, observed no historical, manufacturing or quality concerns.The reported event is adequately mitigated within the risk files, the (ifu), instruction for use provides adequate instruction on the safe use.The ifu states, monitor your dressing and device during operation.If there is increased bleeding, a change in fluid color or pain, contact your healthcare provider with no manufacturing problems observed, no corrective actions are deemed necessary.The probable root cause is no fault found, negative pressure wound therapy is not designed to detect the presence of blood.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 GO
• 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
• 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: 13515576
• MDR Text Key: 285480756
• Report Number: 8043484-2022-00068
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 05000223491000
• UDI-Public: 05000223491000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2022

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
• Device Operator: Health Professional
• Device Model Number: 66021496
• Device Catalogue Number: 66021496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 03/18/2022
• Supplement Dates FDA Received: 03/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female