MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-31 for TODAY CONTRACEPTIVE SPONGE manufactured by Whitehall Laboratories.
[17482441]
Complainant feels that a contraceptive device should be on the open market but should be dispensed by drs only because she has had trouble removing the device on several occasions even though she followed the directions to a "t". She had to have a dr remove it. The device supposedly moves around like it was not properly inserted and when removal is necessary, the loop is hard to get to. She stated that she knows of others who have the same problem. She feels that the co should have a toll free number for advice when these problems occur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000084 |
| MDR Report Key | 11131 |
| Date Received | 1994-01-31 |
| Date of Report | 1993-09-14 |
| Date Added to Maude | 1994-02-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TODAY CONTRACEPTIVE SPONGE |
| Product Code | LLR |
| Date Received | 1994-01-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11131 |
| Manufacturer | WHITEHALL LABORATORIES |
| Manufacturer Address | NEW YORK NY 10017 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-01-31 |