MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MODEL S6 ELECTRIC DERMATOME SET, COMPLETE; N/A

Catalog Number 3539900

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported a dermatome set was used for graft to treat a burn wound.Black liquid from the dermatome spilled over the skin and also caused a deep cut with the dermatome.The procedure couldn't be performed.

Manufacturer Narrative

The dermatome was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.Root cause determination for this issue is not possible, as the product has not returned for evaluation.Based on the risk assessment, no further action or investigation is planned unless the product is returned in the future.

Event Description

N/a.

Manufacturer Narrative

Please note that we erroneously submitted an initial mdr for this case.The customer has clarified that there was no "black liquid/deep cut" event.The confirmed event is: "the stem is free and doesn¿t allow blade movement", which is not a reportable event.

Event Description

N/a.

• Brand Name: MODEL S6 ELECTRIC DERMATOME SET, COMPLETE
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14349321
• MDR Text Key: 291326009
• Report Number: 3004608878-2022-00094
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3539900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2023
• Date Device Manufactured: 04/01/2021
• 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