MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-14 for MDS15310 manufactured by Medline Industries Inc..
[94865050]
It was reported that the patient was undergoing a lipoma removal for a recurrent 11 cm lipoma on his back. Reportedly, during the patients procedure the blade broke off inside of the patient and the surgeon could not remove the blade. According to the facility the blade removal had to be done under fluoroscopy which was not available at the site. The patient was scheduled for follow up to have the blade removed with another clinician at a different site and the patient did not follow up. (b)(6) stated that according to the patient's medical record the blade does not appear to have been removed as of this date. The patient did return to the surgeon to follow up and have the drain and sutures removed and the surgical site healed without incident. No additional details are available. A sample has not yet been returned for evaluation however, due to the reported incident, and in abundance of caution this medwatch is being filed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[94865051]
It was reported a blade broke in a surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2017-00080 |
| MDR Report Key | 7117848 |
| Report Source | USER FACILITY |
| Date Received | 2017-12-14 |
| Date of Report | 2017-12-14 |
| Date of Event | 2017-10-19 |
| Date Added to Maude | 2017-12-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SCALPEL,SAFETY,SS,DISPOSABLE,STERILE |
| Product Code | GDX |
| Date Received | 2017-12-14 |
| Catalog Number | MDS15310 |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-14 |