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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS SOFT PORT STAND ALONE; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
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SMITH & NEPHEW WOUND MANAGEMENT RENASYS SOFT PORT STAND ALONE; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) Back to Search Results
Model Number 66800799
Device Problems Device Alarm System (1012); Decrease in Suction (1146); Disconnection (1171); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2014
Event Type  malfunction  
Event Description
Disconnected part.Port disconnected at canister connection within tubing so that dressing loses suction.The pump does not detect the leak because the system is closed.Port had been on a patient, family attached a plastic orange stick to the outside of the tubing in an attempt to rectify the problem.
 
Event Description
Disconnected part.Port disconnected at canister connection within tubing so that dressing loses suction.The pump does not detect the leak because the system is closed.Port had been on a patient, family attached a plastic orange stick to the outside of the tubing in an attempt to rectify the problem.
 
Manufacturer Narrative
Active investigation in progress; results of investigation will be provided in a supplement report.
 
Manufacturer Narrative
No additional information received to date.
 
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Brand Name
RENASYS SOFT PORT STAND ALONE
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 Key3998827
MDR Text Key4960137
Report Number3006760724-2014-00401
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 10/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number66800799
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date07/11/2014
Date Manufacturer Received07/11/2014
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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