MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-09-11 for ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) UNK manufactured by Johnson & Johnson Medical Brazil (jjmb).
[3802839]
This spontaneous report was received from the mother of a patient, reporting on her daughter, and concerns a female patient of unspecified age from the united states with local case id (b)(6). The patient's height, weight, medical history, and concomitant medication were not provided. On an unspecified date, the patient was treated with all-flex arcing spring diaphragm (silicone) (hdw - contraceptive diaphragm and accessories), one diaphragm as needed/intravaginal for birth control. No date of therapy, lot number or expiration date was provided. Concomitant medications were not reported. The mother reported that one of her daughter's all-flex arcing spring diaphragm (silicone) had a tear in it (device malfunction). It was not specified if the tear was identified before or after patient diaphragm usage. No additional information was provided. The patient outcome was not known tear in diaphragm. This report was serious (medically significant) and reportable (device malfunction). This case, from the same reporter is linked to (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11147367]
The device was not available for retrieval, therefore no lot number was provided. This report was considered reportable as hole in diaphram is medically significant with the potential for pregnancy (medical injury).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242843-2013-00704 |
| MDR Report Key | 3393610 |
| Report Source | 04 |
| Date Received | 2013-09-11 |
| Date of Report | 2013-09-05 |
| Date Facility Aware | 2013-09-04 |
| Report Date | 2013-09-10 |
| Date Reported to FDA | 2013-09-11 |
| Date Reported to Mfgr | 2013-09-11 |
| Date Mfgr Received | 2013-09-05 |
| 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 |
| 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 | 2013-09-11 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 & JOHNSON MEDICAL BRAZIL (JJMB) |
| Manufacturer Address | SAO JOSE DOS CAMPOS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-11 |