MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-23 for UTERINE EXPLORA CURETTE MODEL I 120-3MM manufactured by Milex Products, Inc..
[16833933]
Pt underwent a seemingly uneventful endometrial biopsy in the office for post-menopausal bleeding. Pt called primary care physician next day complaining of leg swelling. Advised to go to er. On arrival pt became hypotensive and transferred to hosp. Continued hypotensive and pt expired in er.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036421 |
| MDR Report Key | 653608 |
| Date Received | 2005-08-23 |
| Date of Report | 2005-08-23 |
| Date of Event | 2005-06-23 |
| Date Added to Maude | 2005-12-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UTERINE EXPLORA CURETTE MODEL I |
| Generic Name | NYLOR CURETTE W/RANDALL-TYPE CUTTING EDGE |
| Product Code | HHK |
| Date Received | 2005-08-23 |
| Model Number | 120-3MM |
| Catalog Number | 120-3MM |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 643071 |
| Manufacturer | MILEX PRODUCTS, INC. |
| Manufacturer Address | 4311 N. NORMANDY CHICAGO IL 60634 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-08-23 |