|
|
| Catalog Number UMG 670 |
| Event Date 07/31/1996 |
|
Patient Outcome
Required Intervention;
|
|
Event Description
|
Uterine perforation during use of uterine manipulator.
|
| |
|
Search Alerts/Recalls
|
|
|
| Brand Name | RUMI |
|---|
| Type of Device | DISPOSABLE UTERINE MANIPULATOR TIP |
|---|
| Baseline Device 510(K) Number | |
|---|
| Baseline Device PMA Number | |
|---|
| Manufacturer (Section F) |
| COOPER SURGICAL |
| 15 forest pkwy |
| shelton CT 06484 |
|
| Manufacturer (Section D) |
| COOPER SURGICAL |
| 15 forest pkwy |
| shelton CT 06484 |
|
| Device Event Key | 75787 |
|---|
| MDR Report Key | 76037 |
|---|
| Event Key | 71616 |
|---|
| Report Number | 76037 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code | LKF |
|---|
| Report Source |
User Facility
|
|---|
| Reporter Occupation |
Nurse
|
| Type of Report
| Initial |
|---|
| Report Date |
08/08/1996 |
| 1 Device Was Involved in the Event | |
| 1 Patient Was Involved in the Event | |
| Date FDA Received | 01/13/1997 |
|---|
| Is This An Adverse Event Report? |
Yes
|
|---|
| Is This A Product Problem Report? |
No
|
|---|
| Device Operator |
Health Professional
|
| Device Catalogue Number | UMG 670 |
|---|
| OTHER Device ID Number | 60/161U |
|---|
| Was Device Available For Evaluation? |
No
|
|---|
| Is The Reporter A Health Professional? |
Yes
|
|---|
| Was the Report Sent to FDA? |
No
|
|---|
| Distributor Facility Aware Date | 07/31/1996 |
|---|
| Device Age | 18 mo |
|---|
| Event Location |
Hospital
|
| Date Report TO Manufacturer | 08/08/1996 |
|---|
| Is the Device an Implant? |
No
|
|---|
| Is this an Explanted Device? |
No Answer Provided
|
|---|
|
|
Database last updated on February 28, 2009
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
