MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT; SKIN GRAFT PRODUCTS

Catalog Number 3539250

Device Problems Calibration Error (1078); Failure to Cut (2587)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 01/08/2014

Event Type  Injury  

Event Description

It was reported 'the equipment is out of calibration, the cuts are not uniform, cutting width is not correct, the equipment has a dent on the top'.Add'l info was received on (b)(6) 2014.The issue was reported as 'bleeding pt due to cuts no uniforms 'during surgery that was indicated for 'graft burnout'.The donor site was the pt's thigh.An 'other graft was necessary, because the graft was with holes.' surgery was delayed 15 minutes due to this issue.

Manufacturer Narrative

To date the device involved in the reported incident has not been received for eval.An investigation has been initiated based on the reported info.

• Brand Name: MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT
• Type of Device: SKIN GRAFT PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; cincinnati OH 45227
• Manufacturer Contact: caren finkelstein ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3687564
• MDR Text Key: 4291006
• Report Number: 3004608878-2014-00025
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3539250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR