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 |