FDA Adverse Event
Death
Summary report: N
MILEX
MDR report key: 962669
·
Received June 30, 2006
Report
- Report Number
- 1216677-2006-00013
- Event Type
- Death
- Date Received
- June 30, 2006
- Report Date
- June 28, 2006
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- MNB
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR EVAL. NO LOT NUMBER INFO WAS PROVIDED. THE INSTRUCTIONS FOR USE LIST CONTRAINDICATIONS INCLUDING USE DURING ACTIVE PELVIC OR CERVICAL INFECTIONS, PELVIC INFLAMMATORY DISEASE AND ANY DISEASES OR CONDITIONS, WHICH COULD UNDER ALL CIRCUMSTANCES CONTRAINDICATE OUTPATIENT SURGICAL TREATMENT (E.G. SEVERE ANEMIA, HEART DISEASE OR CLOTTING MECHANISM DEFICIENCIES). WE ARE UNABLE TO DETERMINE BY WHICH MECHANISM THE PT BECAME HYPOTENSIVE. THERE ARE NO REPORTS OF INJURY ASSOCIATED WITH THIS PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MILEX | ENDOMETRIAL SAMPLING CURETTE | MNB | COOPERSURGICAL, INC. | MX120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |