MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-06-02 for DYNJ41993A manufactured by Medline Industries Inc..
[76540297]
It was reported a cautery device caused a burn to an end-user during use. Facility was contacted for additional information and stated it was determined the cautery device was not the cause of the burns. Facility stated "the issue was more likely to have been caused by an issue with the wall panel. " the facility gave no further details in regards to the injury, use of the cautery device, generator settings, or specifics in regards to the "wall panel. " at this time the reported injury cannot be verified and the complaint cannot be confirmed. A sample was not returned and a root cause cannot be determined. Due to the reported incident and in an abundance of caution this medwatch is being filed. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[76540298]
It was reported a cautery device caused a burn to an end-user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2017-00018 |
| MDR Report Key | 6608408 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-02 |
| Date of Report | 2017-06-02 |
| Date Mfgr Received | 2017-05-05 |
| Date Added to Maude | 2017-06-02 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MEGAN DEBUS |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CAUTERY DEVICE IN C-SECTION PACK |
| Product Code | OHM |
| Date Received | 2017-06-02 |
| Catalog Number | DYNJ41993A |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-06-02 |