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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT LARGE NPWT COTTON FILLER KIT; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
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SMITH & NEPHEW WOUND MANAGEMENT LARGE NPWT COTTON FILLER KIT; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) Back to Search Results
Model Number 66801087
Device Problems Device Alarm System (1012); Break (1069); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/23/2014
Event Type  malfunction  
Event Description
Failure to alarm description: grade 4 pressure ulcer ischeal tuberosity.Surgically debrided.Large wound, close to scrotum.Patient very mobile amputee.Hoisting himself in and out of bed/chair.Drives a car.Dressing would always be a challenge ¿ losing the seal was not a surprise, but the lack of alarm great cause for concern.With drain, better wound management, dressing stayed in place for much longer and pump alarmed when seal broken.
 
Manufacturer Narrative
Production records were reviewed and no issues were found during the manufacturing and/or release of the device.
 
Event Description
Failure to alarm description: grade 4 pressure ulcer ischeal tuberosity.Surgically debrided.Large wound, close to scrotum.Patient very mobile amputee.Hoisting himself in and out of bed/chair.Drives a car.Dressing would always be a challenge ¿ losing the seal was not a surprise, but the lack of alarm great cause for concern.With drain, better wound management, dressing stayed in place for much longer and pump alarmed when seal broken.
 
Manufacturer Narrative
Active investigation in progress; results of investigation will be provided in a supplement report.
 
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Brand Name
LARGE NPWT COTTON FILLER KIT
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 & 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 Key3950491
MDR Text Key5147501
Report Number3006760724-2014-00395
Device Sequence Number1
Product Code BTA
Combination Product (y/n)N
PMA/PMN Number
K110647
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number66801087
Device Lot Number2013080543
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date06/23/2014
Date Manufacturer Received06/23/2014
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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