Brand Name | XENFORM SOFT TISSUE REPAIR MATRIX |
Type of Device | MESH, SURGICAL, NON-SYNTHETIC, UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PRO |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - MARLBOROUGH |
100 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
TEI BIOSCIENCES INCORPORATED |
7 elkins street |
|
boston MA 02127 |
|
Manufacturer Contact |
nancy
cutino
|
100 boston scientific way |
marlborough, MA 01752
|
5086834000
|
|
MDR Report Key | 6822421 |
MDR Text Key | 83727032 |
Report Number | 3005099803-2017-02579 |
Device Sequence Number | 1 |
Product Code |
PAJ
|
UDI-Device Identifier | 08714729774198 |
UDI-Public | (01)08714729774198(17)20170930(10)0001411010 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K060984 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
07/31/2017 |
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 | 09/30/2017 |
Device Model Number | M0068302470 |
Device Lot Number | 0001411010 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/31/2017
|
Initial Date FDA Received | 08/25/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/23/2014 |
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 | 65 YR |
Patient Weight | 73 |