MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2001-03-22 for ALL-FLEX ARCHING SPRING DIAPHRAGM UNK manufactured by R.w. Johnson Pharm. Res. Inst. Usa/div. Of Ortho Pharmaceutical Corp..
[17429577]
Consumer reports that in 1995 or 1996 while using an all-flex arching spring diaphragm, pt became pregnant then miscarried. States prior to this event, pt had been using this same all-flex in between having four children. Reportedly, pt asked their physician if they should be re-fitted each time they had a child, but was told they did not need a new size. Subsequently md has re-fitted pt and found that pt needed a larger diaphragm. No further info available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2211100-2001-00010 |
| MDR Report Key | 322210 |
| Report Source | 04 |
| Date Received | 2001-03-22 |
| Date of Report | 2001-03-06 |
| Date of Event | 1996-01-01 |
| Date Mfgr Received | 2001-02-20 |
| Date Added to Maude | 2001-03-27 |
| 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 |
| Manufacturer Street | 920 U.S. RTE 202 P.O. BOX 300 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9087044504 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALL-FLEX ARCHING SPRING DIAPHRAGM |
| Generic Name | DIAPHRAGM |
| Product Code | HDW |
| Date Received | 2001-03-22 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 311701 |
| Manufacturer | R.W. JOHNSON PHARM. RES. INST. USA/DIV. OF ORTHO PHARMACEUTICAL CORP. |
| Manufacturer Address | 920 U.S. RTE 202 P.O. BOX 300 RARITAN NJ 08869 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-03-22 |