MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-29 for TODAY SPONGE manufactured by Allendale Pharmaceuticals, Inc..
[657690]
I have a problem with the over the counter contraceptive called the sponge. There is a number of flaws with this product. I find it difficult to remove. The material of the sponge is not strong enough for removal. It has not been proven to be safe if pieces of the sponge is left in the body. The advice on the instruction pamphlet on how to remove the sponge is not sufficient or good enough. I may have to go to a health professional to have it removed. One day in 2007. Diagnosis or reason for use: birth control.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002905 |
| MDR Report Key | 874975 |
| Date Received | 2007-06-29 |
| Date of Report | 2007-06-29 |
| Date of Event | 2007-06-28 |
| Date Added to Maude | 2007-07-23 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TODAY SPONGE |
| Generic Name | THE SPONGE |
| Product Code | LLR |
| Date Received | 2007-06-29 |
| Lot Number | 425251 |
| Device Expiration Date | 2007-07-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 861284 |
| Manufacturer | ALLENDALE PHARMACEUTICALS, INC. |
| Manufacturer Address | ALLENDALE NJ 07401 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-29 |