MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for VACURETTE CANNULA 20317 manufactured by Gyrus Acmi, Inc..
[176556334]
Pt was undergoing a d&c for missed ab. Disposable curette opened to field for suction d&c machine. After using the curette, i noticed the tip of curette was broken. The package was checked and pieces of the curette were found in the package. Surgeon was notified. Surgeon repeated a uterine ultrasound and felt uncomfortable that no pieces of the curette were present in the uterus. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092448 |
| MDR Report Key | 9622291 |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-20 |
| Date of Event | 2020-01-13 |
| Date Added to Maude | 2020-01-23 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VACURETTE CANNULA |
| Generic Name | SYSTEM, ABORTION, VACUUM |
| Product Code | HHI |
| Date Received | 2020-01-22 |
| Model Number | 20317 |
| Lot Number | 02194485 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-22 |