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 2017-06-21 for DYNJ54394 manufactured by Medline Industries Inc..
[78026197]
The account reported a cautery tip burned a patient. The physician stated the cautery tip sparked between the tip and the pencil. The tip was guarded and char was noted between the tip and the pencil after use. The patient received a second degree and was treated with a topical dressing. It is unknown what generator was used or the settings. It is unknown how long the device was in use before the spark occurred. The sample was returned and was unable to be tested due to plug and part of the cord being cut off the cautery pencil. Also, cautery blades for the surgical pack were not returned. A root cause cannot be determined. Due to the reported incident and in an abundance of caution this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[78026198]
It was reported the tip of the cautery tip caused a patient to be burned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2017-00019 |
| MDR Report Key | 6656225 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-21 |
| Date of Report | 2017-06-21 |
| Date Mfgr Received | 2017-05-25 |
| Date Added to Maude | 2017-06-21 |
| 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 | 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 TIP IN BREAST AUGMENTATION PACK |
| Product Code | FTN |
| Date Received | 2017-06-21 |
| Catalog Number | DYNJ54394 |
| Lot Number | 17AK0328 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| 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 | 2017-06-21 |