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 |