MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-30 for DILAPAN CERVICAL DILATOR manufactured by Gynotech, Inc..
[22579]
Complainant is regulatory affairs mgr for above firm. A marketing rep from the same firm was at a "national abortion federation meeting" on 3/31 - 4/1/96. The rep found a firm advertising the cervical dilator. Complainant said that the mfr of this product was permanently enjoined from selling this product by federal court on 3/28/95. (*)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001166 |
| MDR Report Key | 32672 |
| Date Received | 1996-04-30 |
| Date of Report | 1996-04-02 |
| Date Added to Maude | 1996-05-08 |
| 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 |
| 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 | DILAPAN CERVICAL DILATOR |
| Generic Name | CERVICAL DILATOR |
| Product Code | MCR |
| Date Received | 1996-04-30 |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 33952 |
| Manufacturer | GYNOTECH, INC. |
| Manufacturer Address | 10 BAEKELAND AVE MIDDLESEX NJ 08846 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-04-30 |