ADJUSTABLE NEOPRENE CHINSTRAP - EXTRA LARGE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-11 for ADJUSTABLE NEOPRENE CHINSTRAP - EXTRA LARGE manufactured by Unk.

MAUDE Entry Details

Report NumberMW5087309
MDR Report Key8692869
Date Received2019-06-11
Date of Report2019-05-30
Date of Event2019-05-30
Date Added to Maude2019-06-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
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 NameADJUSTABLE NEOPRENE CHINSTRAP - EXTRA LARGE
Generic NameSUPPORT, PATIENT POSITION
Product CodeCCX
Date Received2019-06-11
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other 2019-06-11

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