MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-11-26 for ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) UNK manufactured by Johnson & Johnson Medical Brazil (jjmb).
[16735568]
This spontaneous report received from a pt concerns a (b)(6) year-old female from the united states: (b)(4) the pt's medical history and concurrent conditions included: drinks alcohol (1 wine weekly) and non smoker. The pt's weight was 105 pounds and height was 60 inches. The pt had previously experienced allergies when taking sulfa drugs. Other medical history included no known allergies and no drug abuse/illicit drug use. The pt began using ortho all-flex arcing spring diaphragm (silicone) in (b)(6) 2010. Concomitant medications were not reported. The pt reported that since she began using the diaphragm in (b)(6) 2010, she has been experiencing "several bladder infections. " she also stated that she has been prescribed an unspecified antibiotic for treatment. The pt is still using the diaphragm. The pt outcome was unk for the bladder infections. This report was serious (medically significant).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2211100-2010-00024 |
| MDR Report Key | 1908962 |
| Report Source | 04 |
| Date Received | 2010-11-26 |
| Date of Report | 2010-11-04 |
| Date of Event | 2010-05-01 |
| Date Mfgr Received | 2010-10-27 |
| Date Added to Maude | 2011-05-04 |
| 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 | 100 TOURNAMENT DR |
| Manufacturer City | HORSHAM PA 19044 |
| Manufacturer Country | US |
| Manufacturer Postal | 19044 |
| Manufacturer Phone | 2153257685 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) |
| Generic Name | HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES |
| Product Code | HDW |
| Date Received | 2010-11-26 |
| 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 | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL BRAZIL (JJMB) |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-11-26 |