MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-18 for DILAPAN manufactured by Gynotech, Inc..
[15743593]
Elective abortion at an outside clinic, for 15 week gestation, about 11/22/93. Presented one wk later with bleeding, cramping and increased wbc. Clinical impression, septic ab. Pathologist found fragments of cylindrical foreign material in uterine curettings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000416 |
| MDR Report Key | 10976 |
| Date Received | 1994-01-18 |
| Date of Report | 1994-01-03 |
| Date of Event | 1993-11-29 |
| Date Added to Maude | 1994-01-21 |
| 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 |
| Product Code | MCR |
| Date Received | 1994-01-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 10976 |
| Manufacturer | GYNOTECH, INC. |
| Manufacturer Address | MIDDLESEX NJ 08876 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1994-01-18 |