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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME; SKIN GRAFT PRODUCTS
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INTEGRA LIFESCIENCES CORPORATION OH/USA PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME; SKIN GRAFT PRODUCTS Back to Search Results
Catalog Number 3539700
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/13/2020
Event Type  malfunction  
Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported the dermatome malfunctioned in its first use.The patient was prepped, the recipient site was debrided, graft site was identified (thigh to ankle) and prepared, dermatome was tested and did not function.Non sterile dermatome and cable were collected.The cable was draped and passed to the field and hooked to the sterile handpiece and still did not function.Patient was recovered, alternate handpiece and cable were sterilized, procedure was rescheduled later that afternoon (2 hours later).
 
Manufacturer Narrative
The dermatome was returned for evaluation: the device history record (dhr) shows no abnormalities related to the reported failure.Failure analysis: complaint confirmed via evaluation of the device.The motor had seized.Root cause: the motor shaft had still movement and didn't spin freely, motor was seized.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
 
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Brand Name
PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME
Type of Device
SKIN GRAFT PRODUCTS
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
MDR Report Key10826447
MDR Text Key215903112
Report Number3004608878-2020-00678
Device Sequence Number1
Product Code GFD
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3539700
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2020
Date Manufacturer Received12/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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