MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2015-04-01 for ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) manufactured by Johnson And Johnson Medical Brazil (jjmb).
[16075694]
This spontaneous report received from a pt concerns a (b)(6) female from the united states (local id number (b)(6)). The pt's concurrent condition included: abstains from alcohol, allergies (dust/cats) and hay fever. The pt's weight was (b)(6) and height was (b)(6). The pt also has no drug abuse/illicit drug use. The pt was prescribed an all-flex arcing spring diaphragm (silicone, lot number b78cu1, expiration august 2013) for birth control in 1992. Concomitant medications included acetylsalicylic acid for blood clot, fexofenadine for allergies, multivitamins for vitamin supplement, calcium for vitamin supplement, and omega-3 marine triglycerides for vitamin supplement. On an unk date, the pt experienced weight increase, became pregnant and had intentional weight loss. The pt began ortho all-flex arcing spring diaphragm in 1992. The pt reported her weight "ballooned" on an unspecified date while using the diaphragm. The pt reported she became pregnant while using the diaphragm in 2001. The pt reported she believed the diaphragm did not fit properly after her weight gain and she never got re-measured, resulting in her becoming pregnant. The pt reported for an unk reason that she stopped using the ortho all-flex arcing spring diaphragm in 2011 and switched to the generic yaz (drospirenone/ethinyl estradiol) oral birth control pill. The pt reported developing a blood clot in her leg in 2013. She was hospitalized and treated with warfarin for six months. She discontinued the generic yaz (drospirenone/ethinyl estradiol) oral contraceptive pill. The pt reported an intentional weight loss in 2013. The pt reported being diagnosed with factor 5 disorder in (b)(6) 2013. The pt began using the ortho all-flex arcing spring diaphragm again in april 2013. The pt outcome was unk for the weight increase, becoming pregnant and intentional weight loss. This report is associated with a product quality complaint (pqc) reference number (b)(4). This report was serious (serious injury).
Patient Sequence No: 1, Text Type: D, B5
[16472476]
The pt provided a lot number and expiration number for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242843-2015-00319 |
| MDR Report Key | 4663620 |
| Report Source | 04,06 |
| Date Received | 2015-04-01 |
| Date of Report | 2015-03-26 |
| Date Facility Aware | 2015-03-26 |
| Report Date | 2015-03-26 |
| Date Reported to FDA | 2015-03-31 |
| Date Reported to Mfgr | 2015-03-26 |
| Date Mfgr Received | 2015-03-26 |
| Date Added to Maude | 2015-05-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1125 TRENTON HARBOURTON RD |
| 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 (SILICONE) |
| Product Code | HDW |
| Date Received | 2015-04-01 |
| Lot Number | B78CU1 |
| Device Expiration Date | 2013-08-01 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-01 |