MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-19 for CERVIDIL manufactured by Control Therapeutics.
[44199]
The dr returned the product to the pharmacy saying that the gauze wrapper of this product should have a hole in it. This device did not have the hole.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW1010976 |
MDR Report Key | 77201 |
Date Received | 1997-03-19 |
Date of Report | 1997-03-19 |
Date of Event | 1997-03-17 |
Date Added to Maude | 1997-03-21 |
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 |
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 | CERVIDIL |
Generic Name | CERVICAL DILATOR |
Product Code | MCR |
Date Received | 1997-03-19 |
Model Number | NA |
Catalog Number | NA |
Lot Number | MA6R02V |
ID Number | NDC# 0456412363 |
Device Expiration Date | 1999-10-01 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 76920 |
Manufacturer | CONTROL THERAPEUTICS |
Manufacturer Address | * * UK |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1997-03-19 |