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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO
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SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO Back to Search Results
Model Number 66801496
Device Problem Device Alarm System (1012)
Patient Problem Post Operative Wound Infection (2446)
Event Date 08/06/2014
Event Type  malfunction  
Event Description
Failure to alarm.The pump gave no alarm though no exudate was collected, battery functioned properly.After 3 days the dressing was changed.Exudate was collected under the foam.The wound edges where macerated (white) and there was slough on the foam.
 
Event Description
Failure to alarm.The pump gave no alarm though no exudate was collected, battery functioned properly.After 3 days the dressing was changed.Exudate was collected under the foam.The wound edges where macerated (white) and there was slough on the foam.
 
Manufacturer Narrative
Active investigation in progress; results of investigation will be provided in a supplement report.
 
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Brand Name
RENASYS GO
Type of Device
RENASYS GO
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 Key4060866
MDR Text Key5326592
Report Number3006760724-2014-00404
Device Sequence Number1
Product Code BTA
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K083375
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 01/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model Number66801496
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2014
Is the Reporter a Health Professional? No
Distributor Facility Aware Date08/06/2014
Date Manufacturer Received08/06/2014
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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