MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-10-10 for FUTURA SAFETY SCALPEL SMS211 manufactured by Merit Medical Systems, Inc..
[16839964]
The complainant reported, that the inner portion of the safety scalpel came out the back when closing the device after use. It was reported that the inner portion flew across the room and hit the wall. There was no reported patient or clinician harm or injury.
Patient Sequence No: 1, Text Type: D, B5
[16979148]
Method: complaint data was reviewed; results: scalpel; conclusions: no conclusion can be drawn, unusual event. Merit made attempts to locate the suspect device; however, the device could not be found. The device may have been discarded. A lot number was not given; therefore, the device history record could not be reviewed. There were no related incidents identified in the complaint database. The suspect device was not returned and, therefore, no conclusion can be drawn. Merit considers this a rare occurrence and will monitor for any increasing trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721504-2007-00039 |
| MDR Report Key | 925156 |
| Report Source | 08 |
| Date Received | 2007-10-10 |
| Date of Report | 2007-09-11 |
| Date of Event | 2007-07-30 |
| Date Mfgr Received | 2007-09-11 |
| Date Added to Maude | 2007-12-03 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEPHANIE ERSKINE |
| Manufacturer Street | 1600 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 | 2007-10-10 |
| Model Number | NA |
| Catalog Number | SMS211 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 919551 |
| Manufacturer | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Address | SOUTH JORDAN UT 84095 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-10 |