Brand Name | MONOSOF |
Type of Device | SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE |
Manufacturer (Section D) |
COVIDIEN LP LLC NORTH HAVEN |
195 mcdermott rd |
north haven CT 06473 |
|
Manufacturer (Section G) |
COVIDIEN LP LLC NORTH HAVEN |
195 mcdermott rd |
|
north haven CT 06473 |
|
Manufacturer Contact |
tracy
landers
|
5920 longbow drive |
boulder, CO 80301
|
3035816943
|
|
MDR Report Key | 12759214 |
MDR Text Key | 280508104 |
Report Number | 1219930-2021-04644 |
Device Sequence Number | 1 |
Product Code |
GAR
|
UDI-Device Identifier | 10884521075931 |
UDI-Public | 10884521075931 |
Combination Product (y/n) | N |
Reporter Country Code | TW |
PMA/PMN Number | K900531 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative,Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/05/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/31/2022 |
Device Model Number | N-2512 |
Device Catalogue Number | N-2512 |
Device Lot Number | A7K0084X |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/20/2021
|
Initial Date FDA Received | 11/07/2021 |
Date Device Manufactured | 10/03/2017 |
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 |
|
|