Brand Name | PINNACLE PELVIC FLOOR REPAIR KITS |
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) |
BOSTON SCIENTIFIC CORPORATION |
780 brookside drive |
|
spencer IN 47460 |
|
Manufacturer Contact |
carole
morley
|
300 boston scientific way |
marlborough, MA 01752
|
5086834015
|
|
MDR Report Key | 12931199 |
MDR Text Key | 285677500 |
Report Number | 3005099803-2021-07595 |
Device Sequence Number | 1 |
Product Code |
OTP
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K071957 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/05/2021 |
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 Model Number | 831-705 |
Device Catalogue Number | 831-705 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/10/2021 |
Initial Date FDA Received | 12/05/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 57 YR |
Patient Sex | Female |
Patient Weight | 75 KG |
|
|