MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-20 for ALL-FLEX ARCING SPRING DIAPHRAGM UNK manufactured by Ortho-mcneil Pharmaceutical Corp, Usa.
[15176149]
This spontaneous pregnancy report from a pharmacist via call center from (b)(6) concerns a female pt of unspecified age from the united states ((b)(6)). The pt's height, weight and medical history were not provided. The pt was prescribed all-flex arcing spring diaphragm (type unspecified). Concomitant medications were not reported. On an unspecified date, the pt experienced pregnancy, bleeding and reported the device did not work for her (device ineffective). A pharmacist reported a pt stated the diaphragm "did not work for her" and since being prescribed the diaphragm, the pt had unspecified bleeding and had a pregnancy. The pharmacist was uncertain of the timeframe for the events reported. The pt discontinued using the diaphragm on an unspecified date. While attempting to clarify, the pharmacist stated that the info may be inaccurate and she really did not know anything about the situation. The pharmacist did say that there was nothing wrong with the diaphragm. No additional info, including lot number was available as the pharmacist did not have info. The pt outcome was unk for the bleeding, pregnancy and device did not work for her. This report was associated with a product quality complaint (pqc) number ((b)(4)). This report was serious (reportable serious injury).
Patient Sequence No: 1, Text Type: D, B5
[15633937]
Lot number was unavailable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2211100-2013-00867 |
| MDR Report Key | 3564139 |
| Report Source | 05,06 |
| Date Received | 2013-12-20 |
| Date of Report | 2013-12-17 |
| Date Facility Aware | 2013-12-17 |
| Report Date | 2013-12-20 |
| Date Reported to Mfgr | 2013-12-17 |
| Date Mfgr Received | 2013-12-17 |
| Date Added to Maude | 2014-01-10 |
| 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 | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1125 TRENTON-HARBOURTON RD PO BOX 200 |
| Manufacturer City | TITUSVILLE NJ 08560 |
| Manufacturer Country | US |
| Manufacturer Postal | 08560 |
| Manufacturer Phone | 2153257722 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALL-FLEX ARCING SPRING DIAPHRAGM |
| Generic Name | HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES |
| Product Code | HDW |
| Date Received | 2013-12-20 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-MCNEIL PHARMACEUTICAL CORP, USA |
| Manufacturer Address | RARITAN NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-20 |