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 11MM REF. NO. 022011 manufactured by Medgyn Products, Inc..
[18147803]
During an aspiration abortion procedure using 11 mm flexible cannula the cannula was unable to be withdrawn and removed from within the uterus. The client was transferred to the local er/hospital; the tip of the 11mm flex cannula broke off in the uterus. The client had the cannula removed successfully at the hospital. Medgyn was notified of the incident, and the attending md discontinued use of 11 mm flex currette post incidence in august due to the concern with the device. After the second incident (as reported), rptr returned the remaining 11 mm flexible currettes in stock to the manufacturer. Due to the nature of the problem, the agency discontinued use of medgyn 11 mm flex currettes and filed formal report(s) to document problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035235 |
| MDR Report Key | 593122 |
| Date Received | 2005-04-15 |
| Date of Report | 2005-04-07 |
| Date of Event | 2004-08-27 |
| 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 11MM 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 | 11MM FLEX CURRETTE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 582970 |
| Manufacturer | MEDGYN PRODUCTS, INC. |
| Manufacturer Address | 328 N. EISENHOWER LANELOMBARD IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-15 |