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 ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) UNK manufactured by Johnson And Johnson Medical Brazil (jjmb).
[15098155]
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. In 2010, the patient was switched from the ortho coil spring diaphragm (see 2012-01067) to the new ortho all-flex arcing spring diaphragm (silicone) and used weekly for prolapsed uterus (off label use). She then developed hives; site of hives was not reported. The patient removed the diaphragm and the hives resolved. She then received a new diaphragm and the hives returned. On an unspecified date, the patient developed cataracts in both eyes. She underwent outpatient surgery for cataract removal in (b)(6) 2012 and (b)(6)2012. Treatment also included ocuvite (eye vitamin and mineral supplement) and genteal (hypromellose) eye drops. The patient continues to use the ortho all-flex arcing spring diaphragm (silicone). The patient had not recovered from hives; ongoing at the time of this report and had recovered from the bilateral cataracts in 2012. No lot number was provided however, expiration date of 16-jun-2013 was reported. This case is linked to 2012-01067, same patient. This report was serious (device malfunction, medically significant).
Patient Sequence No: 1, Text Type: D, B5
[15275462]
No lot number was provided, however, expiration date of 16-jun-2013 was reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2211100-2012-01071 |
| MDR Report Key | 2906852 |
| Report Source | 04 |
| Date Received | 2013-01-04 |
| Date of Report | 2012-12-20 |
| Date of Event | 2010-01-01 |
| Date Mfgr Received | 2012-12-20 |
| Date Added to Maude | 2013-03-29 |
| 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 |
| 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 | ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) |
| Product Code | HDW |
| Date Received | 2013-01-04 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Device Expiration Date | 2012-06-16 |
| 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 | JOHNSON AND JOHNSON MEDICAL BRAZIL (JJMB) |
| Manufacturer Address | SAO JOSE DOS CAMPOS BR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-04 |