Brand Name | SOUTHMEDIC #11 NON-STERILE DISPOSABLE SCALPEL |
Type of Device | SCALPEL |
Manufacturer (Section D) |
SOUTHMEDIC INC. |
50 alliance blvd |
barrie, L4M5K 3 |
CA L4M5K3 |
|
Manufacturer (Section G) |
SOUTHMEDIC INC. |
50 alliance blvd |
|
barrie, L4M5K 3 |
CA
L4M5K3
|
|
Manufacturer Contact |
tish
whitehead
|
50 alliance blvd |
barrie, ontario L4M5K-3
|
CA
L4M5K3
|
|
MDR Report Key | 9750894 |
MDR Text Key | 192661166 |
Report Number | 8022032-2019-00003 |
Device Sequence Number | 1 |
Product Code |
GES
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
01/03/2020 |
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 | 73-0211 |
Device Catalogue Number | 73-0211 |
Device Lot Number | 040419 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/12/2019 |
Initial Date Manufacturer Received |
12/05/2019 |
Initial Date FDA Received | 02/25/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/04/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|