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

Model Number 66021496

Device Problem Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, while using a renasys go, the pump had no suction when applied to the wound at the clinic.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• 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
• MDR Report Key: 11020790
• MDR Text Key: 221832682
• Report Number: 8043484-2020-04276
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 05000223491000
• UDI-Public: 05000223491000
• Combination Product (y/n): N
• PMA/PMN Number: K152163
• 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: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66021496
• Device Catalogue Number: 66021496
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1