MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-12-21 for DILAPAN manufactured by Gynotech, Inc..
[11869]
The end of the cervical dilator insert is splitting into two sections. Rptr has found seven units which are so affected, all with the same lot. (supplemental numbers are: 0811, 2014, 1114, 1016, 0483, 1015, 2425. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004516 |
| MDR Report Key | 18483 |
| Date Received | 1994-12-21 |
| Date of Report | 1994-12-14 |
| Date of Event | 1994-12-14 |
| Date Added to Maude | 1994-12-22 |
| 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 | PHARMACIST |
| 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 |
| Generic Name | HYGROSCOPIC CERVICAL DILATOR |
| Product Code | MCR |
| Date Received | 1994-12-21 |
| Lot Number | D112993 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18411 |
| Manufacturer | GYNOTECH, INC. |
| Manufacturer Address | MIDDLESEX NJ 08846 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-12-21 |