MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-09 for * 34303 06105F manufactured by Coopersurgical, Inc..
[400600]
The clamp broke off before use. Equipment fault - they come in a box of 10. Pinch clamp keeps water from coming out of balloon. 6 out of 10 have broken. Different people have used them - not user error. Manufacturer will swap out all catheters with this lot number. The patient was undergoing a hysterosonogram.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 585241 |
| MDR Report Key | 585241 |
| Date Received | 2005-03-09 |
| Date of Report | 2005-03-09 |
| Date of Event | 2005-01-19 |
| Report Date | 2005-03-09 |
| Date Reported to FDA | 2005-03-09 |
| Date Added to Maude | 2005-03-29 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | * |
| Generic Name | HS CATHETER |
| Product Code | HGS |
| Date Received | 2005-03-09 |
| Model Number | 34303 |
| Catalog Number | 06105F |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 575071 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | ACKRAD LABORATORIES DIVISIION 95 CORPORATE DRIVE TRUMBULL CT 06611 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-09 |