MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-09-05 for FUTURA SAFETY SCALPEL SMS211 manufactured by Merit Medical Systems, Inc..
[20941556]
A merit sales representative was picking up a used merit scalpel at a user facility and cut his finger while wrapping the device. The scalpel blade was exposed because the user broke the safety mechanism. The merit employee was tested for blood related diseases. Test results are still outstanding.
Patient Sequence No: 1, Text Type: D, B5
[21224362]
Device evaluation anticipated, but no yet begun. Conclusions: other, upon completion of the investigation, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721504-2008-00041 |
| MDR Report Key | 1156424 |
| Report Source | 05,07 |
| Date Received | 2008-09-05 |
| Date of Report | 2008-08-08 |
| Date of Event | 2008-08-05 |
| Date Mfgr Received | 2008-08-08 |
| Date Added to Maude | 2009-07-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEPHANIE ERSKINE |
| Manufacturer Street | 1600 WEST MERIT PKWY. |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012084349 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUTURA SAFETY SCALPEL |
| Generic Name | SCALPEL, ONE-PIECE |
| Product Code | GDX |
| Date Received | 2008-09-05 |
| Returned To Mfg | 2008-08-13 |
| Model Number | NA |
| Catalog Number | SMS211 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Address | SOUTH JORDAN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-05 |