MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2014-12-17 for ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) 75 MM UNK manufactured by Johnson & Johnson Medical Brazil (jjmb).
[20453370]
This spontaneous pregnancy report was received from a female patient of unspecified age (reporting on herself) from the united states (local case identification number (b)(6)). Initial information was processed with additional information received from central complaint vigilance usa on (b)(6) 2014. The patient's weight, height and medical history were not reported. It was not reported if the patient had experienced prior pregnancies. The date of the patient's last menstrual period and expected delivery date were both unspecified. The patient was prescribed the all-flex arcing spring diaphragm (silicone) on an unspecified date. Concomitant medications were not reported. On an unspecified date, the patient experienced a device issue and pregnancy with contraceptive device. The patient reported she was pregnant (date of pregnancy was not provided). The patient did not clarify if the pregnancy was planned or unplanned. The patient also reported after her pregnancy (reported as after childbirth), the diaphragm size decreased from 75 to 70 (device issue). The patient recovered from the pregnancy with contraceptive device on an unknown date and outcome was unknown for the device issue. This report is associated with product quality complaint (pqc) reference number (b)(4). This report was serious (malfunction).
Patient Sequence No: 1, Text Type: D, B5
[20504092]
The patient did not provide contact information. The patient did not provide the diaphragm for evaluation and during the call did not provide a lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242843-2014-01214 |
| MDR Report Key | 4353483 |
| Report Source | 04,06 |
| Date Received | 2014-12-17 |
| Date of Report | 2014-12-10 |
| Date Facility Aware | 2014-12-10 |
| Report Date | 2014-12-10 |
| Date Reported to FDA | 2014-12-17 |
| Date Reported to Mfgr | 2014-12-10 |
| Date Mfgr Received | 2014-12-10 |
| Date Added to Maude | 2015-01-07 |
| 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) |
| Generic Name | HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES |
| Product Code | HDW |
| Date Received | 2014-12-17 |
| Model Number | 75 MM |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-12-17 |