MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-02-25 for SOUTHMEDIC #11 NON-STERILE DISPOSABLE SCALPEL 73-0211 manufactured by Southmedic Inc..
| Report Number | 8022032-2019-00003 |
| MDR Report Key | 9750894 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-25 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-10-31 |
| Date Mfgr Received | 2019-12-05 |
| Device Manufacturer Date | 2019-04-04 |
| Date Added to Maude | 2020-02-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TISH WHITEHEAD |
| Manufacturer Street | 50 ALLIANCE BLVD |
| Manufacturer City | BARRIE, ONTARIO L4M5K3 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4M5K3 |
| Manufacturer G1 | SOUTHMEDIC INC. |
| Manufacturer Street | 50 ALLIANCE BLVD |
| Manufacturer City | BARRIE, L4M5K3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L4M5K3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOUTHMEDIC #11 NON-STERILE DISPOSABLE SCALPEL |
| Generic Name | SCALPEL |
| Product Code | GES |
| Date Received | 2020-02-25 |
| Returned To Mfg | 2019-12-12 |
| Model Number | 73-0211 |
| Catalog Number | 73-0211 |
| Lot Number | 040419 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOUTHMEDIC INC. |
| Manufacturer Address | 50 ALLIANCE BLVD BARRIE, L4M5K3 CA L4M5K3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-25 |