MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-06 for DYNJ905045 manufactured by Medline Industries Inc..
[113388287]
It was reported that the patient undergoing neuro-cervical procedure developed a superficial left neck burn from cautery pencil. Per report, it was unsure what the issue with the cautery pencil was. The reported event immediately occurred during use of the cautery pencil on the patient. Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details. There was no information provided on the extent of the patient burn and what medical intervention was required. The sample was returned for evaluation. No issues with the cautery pencil when tested in cut or coagulation mode was identified. A root cause could not be determined at this time. Due to the reported incident and in an abundance of caution, this medwatch is being filed. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[113388288]
It was reported that the patient undergoing neuro-cervical procedure developed a superficial left neck burn from cautery pencil.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00037 |
| MDR Report Key | 7667883 |
| Date Received | 2018-07-06 |
| Date of Report | 2018-07-06 |
| Date of Event | 2018-06-13 |
| Date Mfgr Received | 2018-06-14 |
| Date Added to Maude | 2018-07-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 2249311514 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | NEURO CERVICAL |
| Product Code | OJG |
| Date Received | 2018-07-06 |
| Returned To Mfg | 2018-06-21 |
| Catalog Number | DYNJ905045 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-07-06 |