Brand Name | MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM |
Type of Device | UTERINE TISSUE REMOVAL DEVICE |
Manufacturer (Section D) |
|
Manufacturer Contact |
craig
callahan, manager
|
250 campus drive |
marlborough, MA 01752
|
5082638859
|
|
MDR Report Key | 4377210 |
MDR Text Key | 15966612 |
Report Number | 1222780-2014-00222 |
Device Sequence Number | 1 |
Product Code |
HIH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K122498 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/21/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/13/2017 |
Device Catalogue Number | 10-401XL |
Device Lot Number | 14F13R |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 12/10/2014 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/21/2014
|
Initial Date FDA Received | 12/19/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/01/2013 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | CONTROL UNIT- SERIAL NUMBER UNKNOWN; MYOSURE HYSTEROSCOPIC-SERIAL # UNK.; SERIAL NUMBER OF THE MYOSURE CONTROL UNIT AND; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; HYSTEROSCOPE NOT PROVIDED BY THE COMPLAINANT. |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|