MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-12 for FORMULA 375-562-000 * manufactured by Stryker Endoscopy.
[4577736]
While the device was being used the port was at 60 degrees and came in contact with the patient's skin and caused a superficial burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3940506 |
| MDR Report Key | 3940506 |
| Date Received | 2014-06-12 |
| Date of Report | 2014-06-12 |
| Date of Event | 2014-06-09 |
| Report Date | 2014-06-12 |
| Date Reported to FDA | 2014-06-12 |
| Date Reported to Mfgr | 2014-07-17 |
| Date Added to Maude | 2014-07-17 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORMULA |
| Generic Name | BUR, SURGICAL |
| Product Code | HTT |
| Date Received | 2014-06-12 |
| Returned To Mfg | 2014-06-09 |
| Model Number | 375-562-000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-12 |