MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-05 for ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) UNK 70 MM manufactured by Johnson And Johnson Medical Brazil (jjmb).
[4464773]
This spontaneous report received from a health professional (medical assistant) concerns a (b)(6) female from the united states (local id number(b)(6)). The patient's concurrent condition included: social drinker. The patient's medical history included: non smoker. Other medical history included: no known allergies, no known drug allergies and no drug abuse/illicit drug use. The patient's weight was (b)(6) and height was (b)(6). The patient was prescribed an all-flex arcing spring diaphragm silicone (lot number ao4fu1) on an unspecified date in (b)(6) 2014 for prevention of pregnancy. Concomitant medications were not reported. In (b)(6) 2014, the patient experienced contraceptive diaphragm uncomfortable. The patient reported the ring on her diaphragm was rigid and stiffer than the fitting kit and it made her uncomfortable. The patient stopped using the diaphragm in (b)(6) 2014. The reporter provided the lot number, but the expiration date was not visible on the package. The diaphragm is available at the office. The patient outcome was unknown for the contraceptive diaphragm uncomfortable. This report was associated with a product quality complaint (pqc) number (pqc number (b)(4) ). This report was non reportable as no serious injury, death, or malfunction occurred. Additional information was received from the (b)(6) on (b)(6) 2014. The case report has been reassessed to serious (potential serious injury). The lot number for the all-flex arcing spring diaphragm silicone (70mm) was amended to a04fu1 (previously reported as lot number ao4fu1). The reporter was contacted for clarification of the issues. The reporter stated that the out ring (part that holds it in place) of the diaphragm was rigid and stiffer than the fitting kit. The reporter was communicating on behalf of a patient. The reporter also clarified that the plastic container/case that stores the diaphragm only had the lot number but no expiration date was printed there. A field sample is available for return in case the site wants it. This report was serious (reportable serious injury).
Patient Sequence No: 1, Text Type: D, B5
[11738752]
The lot number was reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242843-2014-00156 |
| MDR Report Key | 3750752 |
| Report Source | 05,06 |
| Date Received | 2014-03-05 |
| Date of Report | 2014-02-25 |
| Date of Event | 2014-02-01 |
| Date Facility Aware | 2014-02-25 |
| Report Date | 2014-02-25 |
| Date Reported to FDA | 2014-03-04 |
| Date Reported to Mfgr | 2014-02-25 |
| Date Mfgr Received | 2014-02-25 |
| Date Added to Maude | 2014-04-16 |
| 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 | 0 |
| 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 | 2014-03-05 |
| Model Number | UNK |
| Catalog Number | 70 MM |
| Lot Number | A04FU1 |
| ID Number | UNK |
| 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 | 2014-03-05 |