MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2014-04-09 for ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) UNK manufactured by Johnson & Johnson Medical Brazil (jjmb).
[21804458]
This spontaneous report received from a patient concerns a (b)(6) year old white female (reporting on herself) from the united states (local id number (b)(6)). The patient's concurrent conditions included: abstains from alcohol, attention deficit hyperactivity disorder (adhd), depression, high blood pressure and non smoker. The patient's weight was (b)(6) pounds and height was (b)(6) inches. Other medical history included: no known allergies, no known drug allergies and no drug abuse/illicit drug use. The patient was prescribed an all-flex arcing spring diaphragm (silicone, lot number a19fu1, expiration 05/01/2016) on an unspecified date. Concomitant medications included: amlodipine besilate for high blood pressure, hydrochlorothiazide w/losartan for high blood pressure, paroxetine hydrochloride for depression and adderall (amphetamine and dextroamphetamine) for adhd. In (b)(6) 2013, the patient experienced a defect in diaphragm and difficulty in inserting diaphragm and in (b)(6) 2014, the patient experienced a urinary tract infections (uti). The patient began using the all-flex arcing spring diaphragm about 10 years ago. She began using the all-flex arcing spring diaphragm silicone in (b)(6) 2013. She stated that in the beginning of using the new diaphragm that she felt something was wrong with it because it didn't fit right, clarified as she had a lot of trouble getting the diaphragm in (difficulty in inserting diaphragm). She reported developing uti about three (3) weeks ago ((b)(6) 2014). The patient also reported trying the diaphragm during her menstrual cycle and blood leaked right through the diaphragm and the rim seems to be bent. No additional information reported. The diaphragm is available for retrieval at patient's home. The patient has not recovered from the defect in diaphragm and difficulty in inserting diaphragm and the outcome was unknown for the uti. This report was associated with a product quality complaint (pqc) number (pqc number (b)(4)). This report was serious (malfunction).
Patient Sequence No: 1, Text Type: D, B5
[22006877]
The diaphragm is available for retrieval at patient's home.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242843-2014-00221 |
| MDR Report Key | 3799647 |
| Report Source | 04,06 |
| Date Received | 2014-04-09 |
| Date of Report | 2014-04-02 |
| Date Facility Aware | 2014-04-02 |
| Report Date | 2014-04-02 |
| Date Reported to FDA | 2014-04-01 |
| Date Reported to Mfgr | 2014-04-02 |
| Date Mfgr Received | 2014-04-02 |
| Date Added to Maude | 2014-05-27 |
| 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. |
| 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) |
| Generic Name | HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES |
| Product Code | HDW |
| Date Received | 2014-04-09 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | A19FU1 |
| ID Number | UNK |
| Device Expiration Date | 2016-05-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL BRAZIL (JJMB) |
| Manufacturer Address | SAO JOSE DOS CAMPOS BR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-09 |