MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-01-19 for SCALPEL, SAFETY #11, SS, STERIL MDS15311 manufactured by Medline Industries, Inc..
[1016769]
Staff member injured with a contaminated scalpel as safety mechanism was trying to be activated.
Patient Sequence No: 1, Text Type: D, B5
[8167829]
A staff member was injured when trying to activate the safety mechanism on the safety scalpel. The employee health nurse at the facility was not aware that this product had been introduced and did not know if any formal product training had been provided. The injury occurred on 12/29 and resulted in a finger laceration with a contaminated blade. Testing results were not back on the source individual but due to information gathered pertaining to the patient's lifestyle, they opted to provide post exposure prophylactic treatment to the staff member. The sample of the blade involved in the incident was not retained. It is unknown if the staff member was attempting to activate the safety mechanism according to the instructions. No root cause can be identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2009-00005 |
| MDR Report Key | 1291843 |
| Report Source | 06 |
| Date Received | 2009-01-19 |
| Date of Report | 2009-01-15 |
| Date of Event | 2008-12-29 |
| Date Facility Aware | 2009-01-05 |
| Date Added to Maude | 2010-04-12 |
| 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 | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCALPEL, SAFETY #11, SS, STERIL |
| Generic Name | NONE |
| Product Code | GDX |
| Date Received | 2009-01-19 |
| Model Number | MDS15311 |
| Lot Number | H02990 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-19 |