MEDLINE DYND70800 INTERTEK4007556

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-15 for MEDLINE DYND70800 INTERTEK4007556 manufactured by Medline Industries, Inc..

Event Text Entries

[117481513] Charging base for cordless shaver overheated causing burning fumes released in area of use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5079180
MDR Report Key7789077
Date Received2018-08-15
Date of Report2018-08-14
Date of Event2018-08-10
Date Added to Maude2018-08-16
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMEDLINE
Generic NameRAZOR SURGICAL
Product CodeLWK
Date Received2018-08-15
Returned To Mfg2018-08-14
Model NumberDYND70800
Catalog NumberINTERTEK4007556
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer AddressCN


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.