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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO RENTAL DEVICE
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SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO RENTAL DEVICE Back to Search Results
Model Number 66800164R
Device Problem Device Alarm System (1012)
Patient Problems Irritation (1941); Swelling (2091); Complaint, Ill-Defined (2331); Tissue Breakdown (2681)
Event Date 08/01/2014
Event Type  malfunction  
Event Description
Failure to alarm: maceration and irritation from leg.Increased dimension of ulcer.Renasys go system applied to arterial leg ulcer.No exudate in canister, leg swollen and macerated.Pooling of fluid below drape dressing causing significant maceration and breakdown of skin.No alarms sounded despite pooling of fluid.
 
Manufacturer Narrative
Active investigation in progress; results of investigation will be provided in a supplement report.
 
Event Description
Failure to alarm: maceration and irritation from leg.Increased dimension of ulcer.Renasys go system applied to arterial leg ulcer.No exudate in canister, leg swollen and macerated.Pooling of fluid below drape dressing causing significant maceration and breakdown of skin.No alarms sounded despite pooling of fluid.
 
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Brand Name
RENASYS GO RENTAL DEVICE
Type of Device
RENASYS GO RENTAL DEVICE
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 Key4044351
MDR Text Key4803263
Report Number3006760724-2014-00402
Device Sequence Number1
Product Code BTA
Combination Product (y/n)N
PMA/PMN Number
K083375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model Number66800164R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2014
Is the Reporter a Health Professional? No
Distributor Facility Aware Date08/01/2014
Date Manufacturer Received08/01/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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