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

Catalog Number 66801280

Device Problem Defective Alarm (1014)

Patient Problem Skin Erosion (2075)

Event Date 11/23/2017

Event Type  Injury  

Event Description

It was reported that a renasys go had a blockage and the alarm did not set off when the dressing was not watertight anymore which led to a macerated wound.

Manufacturer Narrative

(b)(4).

• Brand Name: RENASYS TCH DEVICE&POWER SPLY
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 7063267
• MDR Text Key: 93073868
• Report Number: 8043484-2017-00293
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66801280
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 29 YR