Brand Name | UPHOLD VAGINAL SUPPORT SYSTEM |
Type of Device | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
FREUDENBERG MEDICAL MIS INC |
2301 centennial boulevard |
|
jeffersonville IN 47130 |
|
Manufacturer Contact |
carole
morley
|
300 boston scientific way |
marlborough, MA 01752
|
5086834015
|
|
MDR Report Key | 10901747 |
MDR Text Key | 218177828 |
Report Number | 3005099803-2020-05655 |
Device Sequence Number | 1 |
Product Code |
OTP
|
Combination Product (y/n) | N |
PMA/PMN Number | K081048 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial |
Report Date |
11/24/2020 |
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 | 03/31/2011 |
Device Model Number | M0068317080 |
Device Catalogue Number | 831-708 |
Device Lot Number | 1ML0031502 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/31/2018
|
Initial Date FDA Received | 11/25/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/16/2010 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|