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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MODEL S HAND PIECE ONLY; SKIN GRAFT PRODUCTS
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INTEGRA LIFESCIENCES CORPORATION OH/USA MODEL S HAND PIECE ONLY; SKIN GRAFT PRODUCTS Back to Search Results
Catalog Number DP0009
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
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 did not took the graft completely and missed a streak and as a consequence a "choppy" skin graft was obtained.A second skin graft was required.Additional information has been requested.
 
Manufacturer Narrative
The device was not returned for evaluation therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
 
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Brand Name
MODEL S HAND PIECE ONLY
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 Key10813252
MDR Text Key215576666
Report Number3004608878-2020-00671
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 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberDP0009
Was Device Available for Evaluation? No
Date Manufacturer Received12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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