MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RENASYS GO NPWT DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66800164

Device Problems Fluid/Blood Leak (1250); Pumping Stopped (1503); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2015

Event Type  Injury  

Event Description

It was report that while the patient was being treated with the device, the pump stopped and the dressing was found separated from the wound.It was also reported that blood was found on the patients sheets.

• Brand Name: RENASYS GO NPWT DEVICE
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer Contact: terry mcmahon ; 970 lake carillon drive; suite 110; st. petersburg, FL 33716 ; 7273993785
• MDR Report Key: 5266659
• MDR Text Key: 229144453
• Report Number: 3006760724-2015-00079
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K083375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800164
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male