DERMATOME BLADES 00880000010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-03-04 for DERMATOME BLADES 00880000010 manufactured by Zimmer Surgical, Inc..

Event Text Entries

[182233593] This event has been recorded by zimmer biomet under (b)(4). Once the investigation is completed, a follow-up/final report will be submitted. Event date: (b)(6) 2019.
Patient Sequence No: 1, Text Type: N, H10


[182233594] It was reported during a skin graft procedure, an unintended laceration occurred due to incorrect placement of the blade inside the dermatome machine. The blade was removed and replaced correctly. The laceration was repaired and skin graft procedure was completed without additional complications. No additional consequences have been reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001526350-2020-00251
MDR Report Key9787676
Report SourceHEALTH PROFESSIONAL,OTHER,USE
Date Received2020-03-04
Date of Report2020-03-04
Date Mfgr Received2020-02-28
Date Added to Maude2020-03-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER SURGICAL, INC.
Manufacturer Street200 WEST OHIO AVENUE
Manufacturer CityDOVER OH 44622
Manufacturer CountryUS
Manufacturer Postal Code44622
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameDERMATOME BLADES
Generic NameDERMATOME BLADE, SINGLE-USE
Product CodeGFD
Date Received2020-03-04
Catalog Number00880000010
Lot Number64357957
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER SURGICAL, INC.
Manufacturer Address200 WEST OHIO AVENUE DOVER OH 44622 US 44622


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention 2020-03-04

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