MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME; NONE

Catalog Number 3539700

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported the motor is not working.There was no pt contact when the repair needs were found.The issue was found during cleaning and sterilization.The devices were being inspected after cleaning.

Manufacturer Narrative

The device involved in the reported incident has been returned.The device eval is in progress.The result of the device eval will be reported in a follow up mdr submission.

• Brand Name: PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME
• Type of Device: NONE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise dr.; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4777974
• MDR Text Key: 18026123
• Report Number: 3004608878-2015-00151
• Device Sequence Number: 1
• Product Code: FZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3539700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2015
• 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