SURGICAL CLIPPER SINGLE BLADE FIXED HEAD NEXGEN 9681 USEN-ADDX5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-08 for SURGICAL CLIPPER SINGLE BLADE FIXED HEAD NEXGEN 9681 USEN-ADDX5 manufactured by 3m Company, 3m Health Care.

Event Text Entries

[67236894]
Patient Sequence No: 1, Text Type: N, H10


[67236895] The 3m clipper handle gets hot and the battery does not hold a charge.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6310494
MDR Report Key6310494
Date Received2017-02-08
Date of Report2016-10-12
Date of Event2016-08-30
Report Date2016-10-12
Date Reported to FDA2016-10-12
Date Reported to Mfgr2016-10-12
Date Added to Maude2017-02-08
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSURGICAL CLIPPER SINGLE BLADE FIXED HEAD NEXGEN
Generic NameRAZOR, SURGICAL
Product CodeLWK
Date Received2017-02-08
Returned To Mfg2016-09-01
Model Number9681
Catalog NumberUSEN-ADDX5
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
Manufacturer3M COMPANY, 3M HEALTH CARE
Manufacturer Address3M CENTER, 2510 CONWAY AVENUE BLDG. 275-5W-06 SAINT PAUL MN 55144 US 55144


Patients

Patient NumberTreatmentOutcomeDate
10 2017-02-08

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