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

Model Number 66801280

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2017

Event Type  malfunction  

Event Description

It was reported that a renasys touch dressing was totally detached but the pump did not give any malfunction signal.

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 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW ENDOSCOPY; 76 s. meridian avenue; oklahoma city OK 73107
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6927668
• MDR Text Key: 89476400
• Report Number: 8043484-2017-00249
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 66801280
• Device Catalogue Number: 66801280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2017
• 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: Initial
• Patient Sequence Number: 1