MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-09-09 for ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) UNK manufactured by Johnson & Johnson Medical Brazil (jjmb).
[3771579]
This spontaneous report was received from a pharmacist, and concerns a (b)(6). The patient's weight and height were not known. Her medical history and concurrent conditions included to known allergies or drug allergies. On (b)(6) 2013, the patient began treatment with the all-flex arcing spring diaphragm (silicone), (hdw - contraceptive diaphragm and accessories), size not specified, (lot number b06eu1, expiration august-2015) one diaphragm as needed/intravaginal, for birth control. Concomitant medications were not reported. A pharmacist called to report a product quality complaint and additionally reported an adverse event on behalf of the patient. On an unspecified date in 2013, the patient noted a hole in the diaphragm (malfunction). No additional information was provided. The patient outcome was not known for hole in diaphragm and uncomfortable. Patient use of the all-flex arcing spring diaphragm (silicone) was ongoing at the time of this report. This report was associated with (b)(4). This report was serious and reportable (malfunction) (medically significant).
Patient Sequence No: 1, Text Type: D, B5
[11261880]
It was unknown if the all-flex arcing spring diaphragm (silicone) was returned to the manufacturer for an evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242843-2013-00696 |
| MDR Report Key | 3393609 |
| Report Source | 05 |
| Date Received | 2013-09-09 |
| Date of Report | 2013-09-03 |
| Date of Event | 2013-01-01 |
| Date Facility Aware | 2013-09-03 |
| Report Date | 2013-09-03 |
| Date Reported to FDA | 2013-09-09 |
| Date Reported to Mfgr | 2013-09-03 |
| Date Mfgr Received | 2013-09-03 |
| Date Added to Maude | 2013-11-01 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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) |
| Product Code | HDW |
| Date Received | 2013-09-09 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | B06EU1 |
| ID Number | UNK |
| Device Expiration Date | 2015-08-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 MO |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-09 |