MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-24 for AO CAST SAW 0295-200 manufactured by Bsn Medical Inc..
[106266461]
Patient Sequence No: 1, Text Type: N, H10
[106266462]
Cast saw malfunctioned and cut the patient's skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7453806 |
| MDR Report Key | 7453806 |
| Date Received | 2018-04-24 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-03-29 |
| Report Date | 2018-04-18 |
| Date Reported to FDA | 2018-04-18 |
| Date Reported to Mfgr | 2018-04-18 |
| Date Added to Maude | 2018-04-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AO CAST SAW |
| Generic Name | INSTRUMENT, CAST REMOVAL, AC-POWERED |
| Product Code | LGH |
| Date Received | 2018-04-24 |
| Model Number | 0295-200 |
| Lot Number | 74470-10 |
| ID Number | MEDICAL ENGINEERING CONTROL # |
| Device Expiration Date | 2018-09-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BSN MEDICAL INC. |
| Manufacturer Address | 5825 CARNEGIE BLVD CHARLOTTE NC 28209 US 28209 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-24 |