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

Model Number MODEL S

Device Problem Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported the device was stopping intermittently.It was reported there was no patient involvement regarding this event.

Manufacturer Narrative

Integra has completed their internal investigation on 10nov2016.The investigation activities included: methods: -evaluation of actual device.-review of device history records.-review of complaint history.Results: device history record reviewed for s-935 manufactured on 06/29/2009 show no abnormalities related 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 09/05/2016.No manufacturing or design related trend has been identified.Conclusion: in summary - manufacturer could not confirm the reason for return or complaint.Unit was returned in good working condition, power issue or broken part was not duplicated during evaluation.

• Brand Name: PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME
• Type of Device: SKIN GRAFT PRODUCTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; 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 ; 6099362393
• MDR Report Key: 6082854
• MDR Text Key: 59805899
• Report Number: 3004608878-2016-00297
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/14/2016

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 Model Number: MODEL S
• Device Catalogue Number: 3539700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2009
• 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