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..
[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
| Report Number | 2211100-1997-00004 |
| MDR Report Key | 115498 |
| Report Source | 04 |
| Date Received | 1997-08-25 |
| Date of Report | 1997-07-30 |
| Date Mfgr Received | 1997-07-29 |
| Date Added to Maude | 1997-08-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALL-FLEX ARCING SPRING DIAPHRAGM |
| Generic Name | DIAPHRAGM |
| Product Code | HDW |
| Date Received | 1997-08-25 |
| Model Number | #65 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 113354 |
| Manufacturer | R. W. JOHNSON PHARM. RESEARCH INST. DIV. OF ORTHO PHARMACEUTICAL CORP. |
| Manufacturer Address | ROUTE 202 PO BOX 300 RARITAN NJ 088690602 US |
| Baseline Brand Name | ALL-FLEX ARCING SPRING DIAPHRAGM |
| Baseline Generic Name | DIAPHRAGM |
| Baseline Model No | #65 |
| Baseline Catalog No | UNK |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1997-08-25 |