MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2009-03-13 for ORTHO COIL SPRING DIAPHRAGM UNK manufactured by Ortho-mcneil Pharmaceutical, Cop..
[15776753]
This spontaneous report from a physician concerns a (b)(6) female from (b)(6). The pt's weight, height and medical history were unk. The pt used a flat spring diaphragm for "several years" (dates unspecified and just ordered an ortho coil spring diaphragm as a replacement. On an unspecified date, the pt used the ortho coil spring diaphragm for an unk indication. Concomitant medications were not reported. On an unspecified date, the pt experienced a vaginal infection (mixed infection of candida albicans and beta strep). The physician planned to treat the pt with an intravaginal antibiotic (clindamycin - dalacin v) and "something else" (as yet undecided). The treatment had not been initiated. The pt continued using the ortho coil spring diaphragm. The adverse events had not resolved this report was serious (medically significant).
Patient Sequence No: 1, Text Type: D, B5
[15798646]
Add'l info was received from mfg quality assurance (qa) on (b)(4) 2008. Results of the qa investigation were found to be within spec. Add'l non-medically relevant info received from mfg qa (quality assurance) on (b)(4) 2009. No deviations were noted during the mfg process for lot number 16e657. On an unspecified date 8 months ago, the pt bought an ortho coil spring diaphragm (75mm, lot number 16e657). The pt used the ortho coil spring diaphragm twice in the past 8 months on unspecified dates. The pt stated when she first bought the ortho coil spring diaphragm it was round, and now it had changed to an "oblong" shape. The pt was concerned there was "something wrong with it" and was concerned the contraceptive function of the diaphragm would be compromised. The pt also had a previous ortho coil spring diaphragm which she not longer used "because it got old", however, she stated it still had a round shape. Results of the qa investigation for lot number 16e657 were found to be within spec. The qa tracking number was (b)(4). Add'l info received from mfg qa on (b)(4) 2009. No deviations were noted during the mfg process for lot number 16e657.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2211100-2009-00002 |
| MDR Report Key | 2624048 |
| Report Source | 01,05 |
| Date Received | 2009-03-13 |
| Date of Report | 2009-03-13 |
| Date Mfgr Received | 2009-03-04 |
| Date Added to Maude | 2012-06-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1000 RT. 202 SOUTH |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 215325768 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO COIL SPRING DIAPHRAGM |
| Generic Name | HDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES. |
| Product Code | HDW |
| Date Received | 2009-03-13 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 16E657 |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-MCNEIL PHARMACEUTICAL, COP. |
| Manufacturer Address | RARITAN NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-13 |