MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-12-17 for ALL-FLEX ARCING SPRING DIAPHRAGM (SILICONE) UNK manufactured by Johnson & Johnson Medical Brazil (jjmb).
[21107354]
This spontaneous report was received from an unknown female (age unspecified), from the united states via central complaint vigilance with local case id (b)(4). An issue report was provided. The patient's height, weight and medical history were not reported. The patient was prescribed all-flex arcing spring diaphragm (silicone, size 65, lot number 0062331000) in (b)(6) 2012. Concomitant medications were not reported. On (b)(6) 2012, the patient experienced a tear along the outside ring of her diaphragm (hole in diaphragm). The patient stated "i put it in last night to try it out and when i took it out this morning, there was a tear in it along the outside ring at the flexible part" on (b)(6) 2012. The patient stated the size of the diaphragm was 65 and the lot number was 0062331000. The lot number was not listed and the patient refused to provide further information stating that her pharmacy was willing to "work with me since i need it by saturday" and would call back if anything changed. The patient outcome was unknown for the tear along the outside ring of her diaphragm. This report was associated with a product quality complaint (pqc) number (pqc number (b)(4)). The issue report concluded that the site was not able to perform a batch record review since the lot number was not provided. The case complaint was closed on (b)(4) 2012 and would be reopened if additional information becomes available and will continue to track and trend. The report disposition was considered undetermined/inconclusive. This report was serious (reportable device malfunction).
Patient Sequence No: 1, Text Type: D, B5
[21274810]
Batch record review cannot be performed, as there is no lot number available. Complaint will be reopened if further information becomes available. Close complaint, continue to track and trend. Evaluation summary: us site was not able to perform a batch record review since the lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242843-2013-00844 |
| MDR Report Key | 3564328 |
| Report Source | 04 |
| Date Received | 2013-12-17 |
| Date of Report | 2012-04-09 |
| Date of Event | 2012-03-26 |
| Report Date | 2013-11-26 |
| Date Reported to Mfgr | 2012-03-26 |
| Date Mfgr Received | 2012-04-09 |
| Date Added to Maude | 2014-02-11 |
| 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 ROAD |
| 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 | 2013-12-17 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 0062331000 |
| 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 | 2013-12-17 |