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 |