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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOEHRINGER LABORATORIES, LCC AVELLE WND-FLO ACUTE UNIT; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP, PRODUCT
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BOEHRINGER LABORATORIES, LCC AVELLE WND-FLO ACUTE UNIT; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP, PRODUCT Back to Search Results
Model Number 446610
Device Problem Electro-Static Discharge (2149)
Patient Problem Electric Shock (2554)
Event Type  Injury  
Manufacturer Narrative
No failure detected, device operated within specification.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).(b)(4).
 
Event Description
It was reported that "nurse describes wearing a nylon gown frequently worn by staff.She was experiencing static electricity from the gown and upon turning off the pump experienced a shock like sensation and saw a spark at the power knob and then pump stopped working.
 
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Brand Name
AVELLE WND-FLO ACUTE UNIT
Type of Device
NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP, PRODUCT
Manufacturer (Section D)
BOEHRINGER LABORATORIES, LCC
500 e. washington st
norristown PA 19403
Manufacturer Contact
jeanette johnson
211 american avenue
greensboro, NC 27409
3362973009
MDR Report Key5368020
MDR Text Key218515166
Report Number1049092-2015-30050
Device Sequence Number1
Product Code OMP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061788
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number446610
Device Lot Number0904122
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2011
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexFemale
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