MAUDE Adverse Event Report: BOEHRINGER LABORATORIES, LCC AVELLE WND-FLO ACUTE UNIT; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 446610

Device Problem Electro-Static Discharge (2149)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

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.

• Brand Name: AVELLE WND-FLO ACUTE UNIT
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): BOEHRINGER LABORATORIES, LCC; 500 e. washington st; norristown PA 19403
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5111865
• MDR Text Key: 27053247
• Report Number: 2518417-2015-30050
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K061788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 446610
• Device Lot Number: 0904122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2011
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1