MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS F/P FOAM DRESSING KIT WITH PORT; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800640

Device Problem Device Alarm System (1012)

Patient Problem Fluid Discharge (2686)

Event Date 10/26/2011

Event Type  malfunction  

Event Description

Failure to alarm: doctor reported that wound had pooling of fluid under the dressing and was not alarming.

Manufacturer Narrative

This medical device report (mdr) is being submitted by smith & nephew as a result of a retrospective review of complaints, including adverse events, as part of corrective and remediation actions following the issuance of the (b)(4) issued (b)(4) 2013 to smith & nephew, inc.Fei no: (b)(4).Smith & nephew is performing a two-year retrospective review of complaint files to re-assess reportability criteria and reporting decisions made for compliant's recorded during the time period under review.This complaint has been re-assessed in accordance under the provisions of 21cfr 803.50 and deemed reportable as an mdr.We are submitting one (1) initial, 30 day report, medwatch fda form 3500a, for a purported device malfunction which occurred while using the renasys f/p foam dressing kit with port.

• Brand Name: RENASYS F/P FOAM DRESSING KIT WITH PORT
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): SMITH & NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st petersburg FL 33716
• Manufacturer (Section G): SMITH AND NEPHEW WOUND MANAGEMENT; 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: 3766364
• MDR Text Key: 4470283
• Report Number: 3006760724-2014-00292
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 66800640
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/26/2011
• Date Manufacturer Received: 10/26/2011
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other