MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2013-12-17 for ORTHO COIL SPRING DIAPHRAGM UNK manufactured by Ortho-mcneil Pharmaceutical Corp, Usa.
[4211294]
This spontaneous report was received from a consumer (pt's sister) and concerns (b)(6) year old female from the united states: (b)(6). The pt's concurrent conditions included: fibromyalgia and high blood pressure. The pt's medical history included: nondrinker and nonsmoker. Other medical history included: no drug abuse/illicit drug use or no known allergies. The pt's height and weight were not reported. The pt was prescribed ortho coil spring diaphragm (latex). Concomitant medications were not reported. On an unspecified date, the pt experienced a hemorrhage, medical device complication, (b)(6), anemia due to ribavirin, deep vein thrombosis and expired device used. The reporter stated that her sister's diaphragm dislodged (medical device complication) resulting in a hemorrhage. The pt reportedly began using the diaphragm twenty (20) years ago (expired device used). Treatment included hospitalization and blood transfusions. The reporter also stated that as a result of the blood transfusions, her sister became "positive for (b)(6)". Treatment included ribavirin and interferon. The reporter continued stating that due to ribavirin therapy, her sister became anemic which he was prescribed procrit (epoetin alfa) and ribavirin therapy was discontinued. The reporter stated eight years ago, her sister developed "numerous deep vein thrombosis (dvt) blood clots all over her body". Treatment included stopping procrit therapy. The pt had a recurrence of the (b)(6) 30 days after stopping ribavirin. The reporter refused any further info. The diaphragm has been discarded and a lot number was not available. The pt has not recovered from the (b)(6) and anemia due to ribavirin, recovered from the hemorrhage on an unspecified date and the outcome was unk for the medical device complication, deep vein thrombosis and expired device used. This report was associated with a product quality complaint (pqc) number (pqc number (b)(4)). This case is reportable (hospitalization). This case, involving the same pt is linked to (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[11435235]
Product has been discarded and product use has spanned historical timeframe, therefore, no lot number or field sample would be available. Product discarded and lot number not available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2211100-2013-00841 |
| MDR Report Key | 3564137 |
| Report Source | 04,06 |
| Date Received | 2013-12-17 |
| Date of Report | 2013-12-03 |
| Report Date | 2013-12-03 |
| Date Reported to Mfgr | 2013-12-03 |
| Date Mfgr Received | 2013-12-03 |
| 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 |
| 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 |
| Manufacturer G1 | JANSSEN PHARMACEUTICALS, INC |
| Manufacturer Street | 1125 TRENTON-HARBOURTON RD PO BOX 200 |
| Manufacturer City | TITUSVILLE NJ 08560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO COIL SPRING DIAPHRAGM |
| Generic Name | HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES |
| Product Code | HDW |
| Date Received | 2013-12-17 |
| 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. Hospitalization | 2013-12-17 |