MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-08-23 for ALL-FLEX ARCING DIAPHRAGM (SILICONE) UNK manufactured by Johnson & Johnson Medical Brazil (jjmb).
[3771078]
This spontaneous report was received from a pharmacist concerning a female patient (age unspecified) from the united states with local case id: (b)(6). The patient's weight, height and medical history were not reported. The patient was treated with the all-flex arcing spring diaphragm (silicone) (hdw - contraceptive diaphragm and accessories), 75 mm, (lot b33eu1, expiration oct-2015), (b)(4), one diaphragm as needed/intravaginal for birth control. Concomitant medications were not reported. A pharmacist reported that a patient picked up her prescription for the all-flex arcing spring diaphragm (silicone) on (b)(6) 2012. On an unspecified date, the patient requested a replacement for the diaphragm because of defects. The pharmacist asked the patient what she meant by "defects" and the patient replied that there was "a small section of the diaphragm that had a little indentation or cut/dent in it" (reported as defect in diaphragm), (device malfunction). The patient returned the diaphragm to the pharmacy on an unspecified date. It was noted that the pharmacist did not have another replacement diaphragm to give to the patient and therefore the patient was without a diaphragm at the time of reporting. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[11267455]
There was no event reported with this product quality complaint for defect in diaphragm. The patient had not recovered from defect in diaphragm. This report is associated with (b)(4). This report was serious (reportable malfunction).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242843-2013-00671 |
| MDR Report Key | 3393594 |
| Report Source | 05 |
| Date Received | 2013-08-23 |
| Date of Report | 2012-11-20 |
| Date of Event | 2012-11-01 |
| Date Facility Aware | 2012-11-20 |
| Report Date | 2013-08-23 |
| Date Reported to FDA | 2013-08-23 |
| Date Reported to Mfgr | 2013-08-20 |
| Date Mfgr Received | 2012-11-20 |
| 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 DIAPHRAGM (SILICONE) |
| Product Code | HDW |
| Date Received | 2013-08-23 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | B33EU1 |
| ID Number | UNK |
| Device Expiration Date | 2015-10-01 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-23 |