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..
[180807108]
The manufacturer was notified on 12/13/2019 by the distributor of a complaint against scalpel 73-0211. They advised that their alert date was (b)(6) 2019 and they have not yet received samples. Should samples be received from the distributor, southmedic shall evaluate them for further investigation. Review of batch records demonstrate that part is within specifications. The submission delay of this report is explained in attachment 1.
Patient Sequence No: 1, Text Type: N, H10
[180807109]
As medical resident went to remove clear pvc cover to scalpel, it was stiff and required extra force and during removal, sliced his fingers. Resident very cautious to use kit now and hospital now providing a swanmorton single use scalpel - which does not have a cover over it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022032-2019-00005 |
| MDR Report Key | 9750917 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-25 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-11-26 |
| Date Mfgr Received | 2019-12-13 |
| Device Manufacturer Date | 2018-10-29 |
| 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 L4M 5K3 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4M 5K3 |
| Manufacturer G1 | SOUTHMEDIC INC. |
| Manufacturer Street | 50 ALLIANCE BLVD. |
| Manufacturer City | BARRIE, L4M 5K3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L4M 5K3 |
| 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 |
| Model Number | 73-0211 |
| Catalog Number | 73-0211 |
| Lot Number | 102918 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOUTHMEDIC INC. |
| Manufacturer Address | 50 ALLIANCE BLVD BARRIE, L4M 5K3 CA L4M 5K3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-25 |