MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-07-02 for SCALPEL, SAFETY #11, SS, STERIL MDS15311 manufactured by Medline Industries, Inc..
[17733136]
Radiologist was performing a breast biopsy. The skin on the pt had been nicked and the radiologist was sliding the safety shield over the blade. The shield apparently slid off of the device. The blade was exposed and the radiologist cut her finger. No suturing was required.
Patient Sequence No: 1, Text Type: D, B5
[17911266]
After the scalpel was used, the end user was sliding the safety shield forward over the blade. It apparently never locked, and instead, fell off the handle. When this happened, the end user cut her finger. Suturing was not required. The pt consented to lab work. All testing came back negative and the end user did not require any post exposure treatment. The blade itself was disposed of. If the handle and sheath are returned, we will eval the prod. A f/u report will be filed if any corrective action is to be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2007-00033 |
| MDR Report Key | 876649 |
| Report Source | 06 |
| Date Received | 2007-07-02 |
| Date of Report | 2007-06-29 |
| Date Facility Aware | 2007-06-06 |
| Date Added to Maude | 2007-12-27 |
| 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 | 3 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PL. |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Street | ONE MEDLINE PL. |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60060 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCALPEL, SAFETY #11, SS, STERIL |
| Generic Name | SCALPEL |
| Product Code | GDX |
| Date Received | 2007-07-02 |
| Model Number | MDS15311 |
| Lot Number | H02992 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 938088 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-07-02 |