MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-01-04 for ORTHO COIL SPRING UNK manufactured by Ortho-mcneil Pharmaceutical, Inc..
[3307214]
This spontaneous report was received from a patient and concerned herself (b)(6) white female from the united states: (b)(6). The patient? S medical history and concurrent conditions included alcohol use (occasional cocktail or wine), grave? S disease, high blood pressure, non-smoker, ruptured aneurysm, and thyroid removed. The patient has previously developed drug allergy when taking dilantin (phenytoin) and hydrochlorothiazide. She also stated an allergy to a preservative in an unspecified anesthesia medication. There was no history of drug abuse/illicit drug use. The patient was prescribed the ortho coil spring diaphragm in 1995 and used weekly for prolapsed uterus (off label use). No lot number was provided. Concomitant medications included levothyroxine, amlodipine, and benazepril. Approx. 4 years ago in 2008, the patient had a bone density test and was diagnosed with osteopenia. She was treated with dietary supplement osteovalin (strontium carbonate, quercetin, hesperidin). The outcome was not provided for osteopenia. This case is linked to 2012-01071, same patient. This report was serious (device malfunction, medically significant).
Patient Sequence No: 1, Text Type: D, B5
[10350992]
No lot number was provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2211100-2012-01067 |
| MDR Report Key | 2906831 |
| Report Source | 04 |
| Date Received | 2013-01-04 |
| Date of Report | 2012-12-20 |
| Date of Event | 2008-01-01 |
| Date Mfgr Received | 2012-12-20 |
| Date Added to Maude | 2013-03-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1125 TRENTON-HARBOURTON ROAD POBOX 200 |
| Manufacturer City | TITUSVILLE NJ 08560 |
| Manufacturer Country | US |
| Manufacturer Postal | 08560 |
| Manufacturer Phone | 2153257722 |
| Manufacturer G1 | ORTHO-MCNEIL PHARMACEUTICAL, INC. |
| Manufacturer Street | 1000 RT. 202 SOUTH |
| Manufacturer City | RARITAN NJ 08869060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08869 0602 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO COIL SPRING |
| Product Code | HDW |
| Date Received | 2013-01-04 |
| 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, INC. |
| Manufacturer Address | 1000 RT. 202 SOUTH RARITAN NJ 08869060 US 08869 0602 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-04 |