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

Catalog Number 3539250

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported the dermatome device works intermittently.The problem did not stop the procedure.The device was in contact with the patient, however; it is reported there was no patient injury.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

• Brand Name: MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT
• Type of Device: SKIN GRAFT PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise dr.; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4307470
• MDR Text Key: 5270905
• Report Number: 3004608878-2014-00224
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3539250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1