ALL-FLEX ARCING SPRING DIAPHRAGM #65 UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-08-25 for ALL-FLEX ARCING SPRING DIAPHRAGM #65 UNK manufactured by R. W. Johnson Pharm. Research Inst. Div. Of Ortho Pharmaceutical Corp..

Event Text Entries

[74877] Follow-up info 8/10/97: medical records from hospital provided by dr state pt was using a #65 all flex arcing spring diaphragm. Pt was hospitalized on 7/15/97 and not as previously reported. Pt was diagnosed with migrane headaches and nausea. She was discharged on 7/17/97 in stable condition. She was put on phenergan (promethazine) 12. 5 mg pr q6h prn, isocet 1 q6h prn #20, keflex (cephalexin) 250 mg q. I. D. For 10 days.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2211100-1997-00004
MDR Report Key115498
Report Source04
Date Received1997-08-25
Date of Report1997-07-30
Date Mfgr Received1997-07-29
Date Added to Maude1997-08-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALL-FLEX ARCING SPRING DIAPHRAGM
Generic NameDIAPHRAGM
Product CodeHDW
Date Received1997-08-25
Model Number#65
Catalog NumberUNK
Lot NumberUNK
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key113354
ManufacturerR. W. JOHNSON PHARM. RESEARCH INST. DIV. OF ORTHO PHARMACEUTICAL CORP.
Manufacturer AddressROUTE 202 PO BOX 300 RARITAN NJ 088690602 US
Baseline Brand NameALL-FLEX ARCING SPRING DIAPHRAGM
Baseline Generic NameDIAPHRAGM
Baseline Model No#65
Baseline Catalog NoUNK
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 1997-08-25

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