MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2012-06-29 for SAFETY SCALPEL SMS211P/D manufactured by Merit Medical Systems, Inc..
[2684003]
The user reported that the scalpel blade will not recoil into the handle because the blade had shot out of the handle. No harm or injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9973736]
Device eval: the suspect device has not been returned for eval. The user did not indicate if this was the initial use of the device. The eval is in process. A follow-up report will be submitted when the device eval has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721504-2012-00068 |
| MDR Report Key | 2641411 |
| Report Source | 07,08 |
| Date Received | 2012-06-29 |
| Date of Report | 2012-06-14 |
| Date of Event | 2012-06-14 |
| Date Mfgr Received | 2012-06-14 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2012-10-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASEY HUGHES |
| Manufacturer Street | 1600 WEST MERIT PKWY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8013164932 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFETY SCALPEL |
| Generic Name | MANUAL SURGICAL INSTRUMENTS FOR GENERAL |
| Product Code | GDX |
| Date Received | 2012-06-29 |
| Catalog Number | SMS211P/D |
| Lot Number | D125509 |
| Device Expiration Date | 2015-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2012-06-29 |