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 |