MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-17 for ALL-FLEX ARCING SPRING DIAPHRAGM UNK manufactured by Ortho-mcneil Pharmaceutical, Corp.
[20322818]
This spontaneous report was initially received from a health professional concerns a female patient of unspecified age from the united states: (b)(6). The patient's height, weight, and medical history were not reported. The patient was prescribed all-flex arcing spring diaphragm (latex size 75). Concomitant medications were not reported. On an unspecified date, the patient experienced a hole in her diaphragm. The patient called to report that she had "developed a hole" in her diaphragm that she purchased "5 years ago". The patient refused to offer any further information and the product packaging has been discarded. The mfr received the complaint on (b)(6) 2012. A batch record review cannot be performed, as there is no lot number available. The complaint was closed on (b)(6) 2012. The disposition was reported as undetermined/inconclusive. The mfr will continue to track and trend. The patient outcome was unspecified for the hole in diaphragm. This report was associated with a product quality complaint (pqc) number (pqc number (b)(4)). This report was serious (reportable device malfunction).
Patient Sequence No: 1, Text Type: D, B5
[20476248]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2211100-2013-00847 |
| MDR Report Key | 3573721 |
| Report Source | 05,06 |
| Date Received | 2013-12-17 |
| Date of Report | 2012-06-22 |
| Report Date | 2013-11-26 |
| Date Reported to Mfgr | 2012-06-22 |
| Date Mfgr Received | 2012-06-22 |
| Date Added to Maude | 2014-02-20 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1125 TRENTON-HARBOURTON RD PO BOX 200 |
| 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 |
| Generic Name | CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES |
| Product Code | HDW |
| Date Received | 2013-12-17 |
| 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 | ORTHO-MCNEIL PHARMACEUTICAL, CORP |
| Manufacturer Address | RARITAN NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-17 |