MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-12-13 for SAFETY SCALPEL SMS211P/C manufactured by Merit Medical Systems, Inc..
[1718795]
The customer reported that upon retraction of the blade, the blade flew through the back of the handle and on to the floor. No harm or injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8813233]
Device evaluation: the suspect device will not be returned for evaluation/investigation. The complaint data base was reviewed and found no similar complaints for this lot number. A follow-up report will be submitted when the device evaluation has been completed. Evaluation conclusions: a follow-up report will be submitted when the device evaluation has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721504-2010-00422 |
| MDR Report Key | 1949789 |
| Report Source | 08 |
| Date Received | 2010-12-13 |
| Date of Report | 2010-11-15 |
| Date of Event | 2010-11-15 |
| Date Mfgr Received | 2010-11-18 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2011-08-03 |
| 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 | 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 | 2010-12-13 |
| Catalog Number | SMS211P/C |
| Lot Number | D934401 |
| Device Expiration Date | 2013-09-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 1600 WEST MERIT PKWY. SOUTH JORDAN UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-13 |