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

Model Number 66801309

Device Problem Partial Blockage (1065)

Patient Problem Tissue Damage (2104)

Event Date 12/31/2016

Event Type  Injury  

Event Description

Due to the blockage issue, the doctor has changed several softport and this has caused skin maceration in the dressing area.

• Brand Name: RENASYS EZ MAX
• 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: 6510895
• MDR Text Key: 73372932
• Report Number: 8043484-2017-00120
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K132446
• 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: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 66801309
• Device Catalogue Number: 66801309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: No
• 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