MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-08-23 for ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) UNK manufactured by Johnson & Johnson Medical Brazil (jjmb).
[17949097]
This spontaneous report was received from 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's device history included ortho all flex diaphragm use thirteen years earlier (date not specified). On an unspecified date, the patient was prescribed the all-flex arcing spring diaphragm (silicone) (hdw - contraceptive diaphragm and accessories), 70 mm, one diaphragm as needed/intravaginal, for birth control. No concomitant medications were reported, and purchased the all-flex arcing spring diaphragm (silicone), lot number b13eu1, on (b)(6) 2012. The patient reported that the new diaphragm seemed like it was a different type of material than the previous diaphragm. It was "soft" and it was a different color described as "whiter. " on (b)(6) 2013, the patient inspected the diaphragm by holding it up to the light and reported that it was "fine. " after the patient removed the diaphragm on (b)(6) 2013, she observed a tiny hole (device malfunction). The diaphragm was available for retrieval from the patient's home. (b)(4). There was no event reported with this product quality complaint for hole in diaphragm. (b)(4). The patient outcome was not reported for hole in diaphragm. This report was serious (reportable malfunction). Additional information received from the manufacturer complaint management on (b)(4) 2013 and processed with the same version (0).
Patient Sequence No: 1, Text Type: D, B5
[18232543]
The diaphragm device was evaluated following product complaint received (b)(4). According to the visual analysis performed on the diaphragm, there was no issue observed related to a different type of material and no difference in color, described as "whiter. " a tear in the thickness of the diaphragm was observed. Functional tests such as dome thickness and rim thickness were performed on the diaphragm, and all results met the quality requirements. Following analyses of the deviation, it was verified that the tear defect was caused by an irregularity in the "remotion" of the diaphragm. The complaint was to be logged in the company trend analysis for further evaluation and, if applicable, improvements in their process and products.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242843-2013-00670 |
| MDR Report Key | 3393606 |
| Report Source | 04 |
| Date Received | 2013-08-23 |
| Date of Report | 2013-01-23 |
| Date of Event | 2013-01-23 |
| Date Facility Aware | 2013-01-23 |
| Report Date | 2013-08-23 |
| Date Reported to FDA | 2013-08-23 |
| Date Reported to Mfgr | 2013-08-21 |
| Date Mfgr Received | 2013-01-23 |
| 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 | 2013-08-23 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | B13EU1 |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |