MAUDE Adverse Event Report:; DERMATOME

; DERMATOME

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Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 12/09/2019

Event Type malfunction

Event Description

Dermatome cut a deeper graft for the patient than the (predetermined?) setting.

1 Device was Involved in the Event
Type of Device	DERMATOME
MDR Report Key	9928191
MDR Text Key	186539492
Report Number	9928191
Device Sequence Number	1
Product Code	GFD
Combination Product (y/n)	N
Number of Events Reported	1
Summary Report (Y/N)	N
Report Source	User Facility
Reporter Occupation	Risk Manager
Type of Report	Initial
Report Date	03/12/2020
1 Patient was Involved in the Event
Date FDA Received	04/06/2020
Is this an Adverse Event Report?	No
Is this a Product Problem Report?	Yes
Device Operator	Other
Was Device Available for Evaluation?	Yes
Is the Reporter a Health Professional?	No
Was the Report Sent to FDA?	Yes
Date Report Sent to FDA	03/12/2020
Event Location	Hospital
Date Report to Manufacturer	04/06/2020
Is This a Reprocessed and Reused Single-Use Device?	No
Type of Device Usage	N
Patient Sequence Number	1
Patient Outcome(s)	Other;
Patient Age	15695 DA