Brand Name | ARCTV TRANSVAGINAL SLING SYSTEM |
Type of Device | SLING |
Manufacturer (Section D) |
UROCURE |
701 n. 3rd st. |
suite 110 |
minneapolis MN 55401 |
|
Manufacturer (Section G) |
BIOMERICS |
10351 xylon ave n |
suite 100 |
minneapolis MN 55445 |
|
Manufacturer Contact |
denise
lenz
|
701 n. 3rd st. |
suite 110 |
minneapolis, MN 55401
|
6129653445
|
|
MDR Report Key | 15910505 |
MDR Text Key | 304786376 |
Report Number | 3013859837-2022-00002 |
Device Sequence Number | 1 |
Product Code |
OTN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K183134 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/02/2022 |
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 | A-TV-1001 |
Device Catalogue Number | A-TV-1001 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/04/2022
|
Initial Date FDA Received | 12/02/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 Sex | Female |