MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-22 for SAFETY SCALPEL WITH POLYMER COATED SURGICAL BLADE 73-0611 manufactured by Southmedic Inc.
[26449274]
Patient Sequence No: 1, Text Type: N, H10
[26449275]
The safety cover does not always slide easily or not at all. This can cause potential laceration to the user if they continue to try to slide the safety cover. So far, no staff or patients have been harmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5093510 |
| MDR Report Key | 5093510 |
| Date Received | 2015-09-22 |
| Date of Report | 2015-09-21 |
| Date of Event | 2015-09-08 |
| Report Date | 2015-09-21 |
| Date Reported to FDA | 2015-09-21 |
| Date Reported to Mfgr | 2015-09-21 |
| Date Added to Maude | 2015-09-22 |
| 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 | 0 |
| 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 | SAFETY SCALPEL WITH POLYMER COATED SURGICAL BLADE |
| Generic Name | SCALPEL, ONE-PIECE |
| Product Code | GDX |
| Date Received | 2015-09-22 |
| Catalog Number | 73-0611 |
| Lot Number | 020915 |
| ID Number | #11 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOUTHMEDIC INC |
| Manufacturer Address | 537 N SPENCER MESA AZ 85203 US 85203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-22 |