MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-09 for DILAPAN UNKNOWN manufactured by Gynotech, Inc..
[11145]
Hygroscopic dilator broke. A pt retained distal pieces in uterus. The pt was admitted for d&c, and remaining portions were successfully retrieved. No adverse outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 20727 |
| MDR Report Key | 20727 |
| Date Received | 1995-03-09 |
| Date of Report | 1995-03-06 |
| Date of Event | 1995-02-27 |
| Date Facility Aware | 1995-02-27 |
| Report Date | 1995-03-06 |
| Date Reported to FDA | 1995-03-06 |
| Date Added to Maude | 1995-03-28 |
| 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 | 1995-03-09 |
| Model Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 20612 |
| Manufacturer | GYNOTECH, INC. |
| Manufacturer Address | MIDDLESEX NJ 08846 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-03-09 |