MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for INTEGRA PADGETT DERMATOMES manufactured by Integra Lifesciences Corporation.
[186303526]
I (manager of sterile processing department) was called to room by the doctor. He wanted me to look at a piece of equipment he had on the sterile field that he did not think was working correctly. I came into the room. He turned on the power to the item in question to demonstrate how it was malfunctioning. The surgical technologist and i agreed it was not working properly. The tray containing that particular piece was removed from the sterile field. A tray containing a new item was delivered to the sterile field. It was checked by the surgeon. With the surgical technologist as well as myself watching. We all agreed the new item was working properly. The case then continued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9897159 |
| MDR Report Key | 9897159 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-17 |
| Report Date | 2020-03-25 |
| Date Reported to FDA | 2020-03-25 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGRA PADGETT DERMATOMES |
| Generic Name | DERMATOME |
| Product Code | GFD |
| Date Received | 2020-03-30 |
| Model Number | S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 1100 CAMPUS ROAD PRINCETON NJ 08540 US 08540 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |