MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RENASYS F SMALL W / SOFT PORT; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 66800794

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Irritation (1941); Swelling (2091)

Event Date 11/28/2016

Event Type  Injury  

Event Description

It was reported during use patient had irritations, blistering and redness at the edge of the wound.

• Brand Name: RENASYS F SMALL W / SOFT PORT
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 970 lake carillon drive; st petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76. s meridan avenue; oklahoma city OK 73107
• Manufacturer Contact: claudia de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6217746
• MDR Text Key: 63693317
• Report Number: 3006760724-2017-00001
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K162129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 66800794
• Device Catalogue Number: 66800794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2017
• Initial Date FDA Received: 01/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1