MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-02-18 for SAFETY SCALPEL MDS15311 manufactured by Medline Industries, Inc..
[4354775]
As the incision was being made, the blade broke and was retrieved from the surgical site.
Patient Sequence No: 1, Text Type: D, B5
[11574608]
The blade broke as the surgeon was making a new incision during an arthroscopy procedure. The piece fell into the surgical site and was retrieved with the aid of x-ray and a scope. There was no pt injury or need for further intervention. The sample has not been returned to us for evaluation. A root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00020 |
| MDR Report Key | 3659895 |
| Report Source | 05,06 |
| Date Received | 2014-02-18 |
| Date of Report | 2014-02-13 |
| Date of Event | 2014-01-23 |
| Date Mfgr Received | 2014-01-24 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2014-03-06 |
| 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 | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFETY SCALPEL |
| Product Code | GDX |
| Date Received | 2014-02-18 |
| Catalog Number | MDS15311 |
| Lot Number | 0032178 |
| 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 | 2014-02-18 |