ALL-FLEX KIT #80 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-19 for ALL-FLEX KIT #80 * manufactured by Ortho Pharmaceutical.

Event Text Entries

[30181] Did not arch correctly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1010298
MDR Report Key50242
Date Received1996-11-19
Date of Report1996-11-08
Date of Event1996-11-08
Date Added to Maude1996-11-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameALL-FLEX KIT
Generic NameDIAPHRAGM
Product CodeHDW
Date Received1996-11-19
Model Number#80
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key50952
ManufacturerORTHO PHARMACEUTICAL
Manufacturer AddressRT 202 PO BOX 300 RARITAN NJ 088690602 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1996-11-19

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