MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME

Catalog Number 3539700

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported the device does not work.The user tried a new cord.The voltage of power supply was 48 volts but the device was still "dead." there was no patient involvement for this event.

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.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2015.The additional investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: device history record reviewed for s-611 manufactured on 07/17/2007 show no abnormalities relate to reported incident found.This device passed all required inspection points with no associated mrr¿s, variances or rework.This device was last serviced on 12/05/2012.A two year look back for this reported failure for this product id shows that (b)(4) complaints were received including this case.Conclusion: in summary we are unable to confirm or duplicate the end users experience.The returned unit passed all functional testing requirements, however general maintenance is required as this device was manufactured in 2007 and last serviced in 2012.

• Brand Name: PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME
• Type of Device: PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 8006542873
• MDR Report Key: 4898267
• MDR Text Key: 6537423
• Report Number: 3004608878-2015-00180
• 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,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2007
• 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