Type of Device | CANNULA, MANIPULATOR/INJECTOR, UTERINE |
Manufacturer (Section D) |
CATHETER RESEARCH, INC./THOMAS MEDICAL INC. |
6102 victory way |
indianapolis IN 46278 |
|
MDR Report Key | 6857845 |
MDR Text Key | 85802890 |
Report Number | 6857845 |
Device Sequence Number | 1 |
Product Code |
LKF
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/01/2017,08/22/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 02/01/2021 |
Device Model Number | TMI1151 |
Device Catalogue Number | TMI1151 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/01/2017 |
Event Location |
Ambulatory Surgical Facility
|
Date Report to Manufacturer | 08/01/2017 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 09/12/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Treatment | NO OTHER THERAPIES; NO, ONLY A TENACULUM ON THE ANTERIOR LIP OF CERVIX |
Patient Age | 31 YR |
Patient Weight | 48 |
|
|