Brand Name | TYRX ABSORBABLE ANTIBACTERIAL ENVELOPE |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
RICE CREEK MFG |
7000 central ave ne |
fridley MN 55432 |
|
Manufacturer (Section G) |
RICE CREEK MFG |
7000 central ave ne |
|
fridley MN 55432 |
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 10786007 |
MDR Text Key | 214581541 |
Report Number | 6000030-2020-00229 |
Device Sequence Number | 1 |
Product Code |
FTL
|
UDI-Device Identifier | 00763000101602 |
UDI-Public | 00763000101602 |
Combination Product (y/n) | Y |
Reporter Country Code | US |
PMA/PMN Number | K130943 |
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 |
11/04/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/04/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 04/30/2020 |
Device Model Number | CMRM6122 |
Device Catalogue Number | CMRM6122 |
Device Lot Number | R126502 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/13/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | 5076-52 LEAD, 5076-58 LEAD, W3DR01 IPG |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 77 YR |
Patient Weight | 83 |