MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-08 for ARCHING SPRING DIAPHRAGM manufactured by Ortho Pharmaceutical Corp..
[8186]
Anaphylactic shock secondary to latex glove and diaphragm. Occurred within minutes of diaphragm fitting. Pt developed hypotension, laryngeal spasm, and bronchoconstriction necessitating immediate emergency intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000680 |
| MDR Report Key | 11383 |
| Date Received | 1994-02-08 |
| Date of Report | 1994-01-26 |
| Date of Event | 1994-01-13 |
| Date Added to Maude | 1994-02-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHING SPRING DIAPHRAGM |
| Product Code | HDW |
| Date Received | 1994-02-08 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11383 |
| Manufacturer | ORTHO PHARMACEUTICAL CORP. |
| Manufacturer Address | RARITAN NJ 088690602 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1994-02-08 |