MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-05 for ALL-FLEX ARCING SPRING DIAPHRAGM UNK manufactured by Ortho-mcneil Pharmaceutical Corp., Usa.
[4116127]
This spontaneous report was initially received from a pharmacist via alliance healthcare and concerned 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 or silicone was not provided). The diaphragm's ndc number provided was (b)(4). Concomitant medications were not reported. On an unspecified date, the patient experienced a hole in the diaphragm. A pharmacist reported that one of his patient's returned an ortho all flex diaphragm to the pharmacy as it had "a hole in it" (medical device complication). The diaphragm was not available for retrieval as was the lot number since the pharmacist had disposed of the diaphragm. The manufacturer received the complaint on (b)(4) 2010. Since it was not identified which diaphragm was prescribed to the patient (latex or silicone), the complaint was sent to both manufacturing sites. Results were received from the us site that manufactures the latex diaphragm. A batch record review was not possible without knowing the lot number. The complaint was closed on (b)(6) 2010. The disposition was reported as undetermined/inconclusive. The manufacturer will continue to track and trend. The patient outcome was unspecified for the hole in diaphragm. This report was associated with product quality complaint (pqc) number (pqc number (b)(4)). This report was serious (reportable device malfunction).
Patient Sequence No: 1, Text Type: D, B5
[11389600]
No lot number was provided at this time. If a valid lot number is received further evaluation will be performed. A batch record review is not possible without knowing the lot number. Close complaint, continue to track and trend. A batch record review is not possible without knowing the lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2211100-2013-00835 |
| MDR Report Key | 3536584 |
| Report Source | 05,06 |
| Date Received | 2013-12-05 |
| Date of Report | 2010-11-18 |
| Report Date | 2013-12-04 |
| Date Reported to Mfgr | 2010-11-18 |
| Date Mfgr Received | 2010-11-18 |
| Date Added to Maude | 2014-01-09 |
| 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. P.O. 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 | HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES |
| Product Code | HDW |
| Date Received | 2013-12-05 |
| 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., USA |
| Manufacturer Address | RARITAN NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-05 |