MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-15 for MEDGYN FLEXIBLE CURETTE 11 MM REF. NO. 022011 manufactured by Medgyn Products, Inc..
[402451]
During a vaccum aspiration abortion procedure using 11 mm flexible cannula the tip broke off in the uterus durng the procedure. The cervix was dilated and the tip was removed successfully from the uterus. Med gyn was notified of the incident and rptr returned the remaining 11 mm flexible cannulas to the manufacturer. This was the second incident (as reported) in which the tip of 11 mm flex cannula broke off. Due to the nature of the problem rptr has decided to discontinue the use of 11 mm currette and filed a formal report to document problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035236 |
| MDR Report Key | 593134 |
| Date Received | 2005-04-15 |
| Date of Report | 2005-04-07 |
| Date of Event | 2005-03-22 |
| Date Added to Maude | 2005-04-21 |
| 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 | 3 |
| 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 | MEDGYN FLEXIBLE CURETTE 11 MM REF. NO. 022011 |
| Generic Name | 11 MM FLEXIBLE CURRETTE |
| Product Code | HCY |
| Date Received | 2005-04-15 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | 11 MM FLEX CURRETTE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 582980 |
| Manufacturer | MEDGYN PRODUCTS, INC. |
| Manufacturer Address | 328 N. EISENHOWER LANELOMBARD IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-15 |