MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-31 for DILAPAN UNKNOWN manufactured by Gynotech, Inc..
[15298]
Pt undergoing therapeutic dilation and evaluation. On attempted removal of cervical dilator, broke off. Pt was kept in o. R. , under anesthesia, so that pieces could be recovered with a curette.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 26245 |
| MDR Report Key | 26245 |
| Date Received | 1995-07-31 |
| Date of Report | 1995-02-24 |
| Date of Event | 1994-12-13 |
| Date Facility Aware | 1995-02-10 |
| Report Date | 1995-02-24 |
| Date Reported to Mfgr | 1995-02-24 |
| Date Added to Maude | 1995-10-02 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DILAPAN |
| Generic Name | CERVICAL DILATOR |
| Product Code | MCR |
| Date Received | 1995-07-31 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 26908 |
| Manufacturer | GYNOTECH, INC. |
| Manufacturer Address | P.O. BOX 355 MIDDLESEX NJ 08846 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-07-31 |