MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-31 for SERCO 41963 MADE IN JAPAN manufactured by U:s:food Service.
[18947131]
On 10/27/98, the patient's mother picked up a fork from the patient's lunch tray to feed the patient. Suddenly, she saw 2 rounded metal 1. 5 mm objects on the plate. Further inspection by the dir. Of dietary dept. Showed more rounded objects stuck between the sticks of several forks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 196079 |
| MDR Report Key | 196079 |
| Date Received | 1998-10-31 |
| Date of Report | 1998-10-29 |
| Date of Event | 1998-10-27 |
| Date Facility Aware | 1998-10-27 |
| Report Date | 1998-10-27 |
| Date Reported to FDA | 1998-10-29 |
| Date Added to Maude | 1998-11-12 |
| 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 | 0 |
| 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 | SERCO |
| Generic Name | TABLE WARE (FORK) |
| Product Code | ILC |
| Date Received | 1998-10-31 |
| Returned To Mfg | 1998-10-27 |
| Model Number | 41963 |
| Catalog Number | MADE IN JAPAN |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 190505 |
| Manufacturer | U:S:FOOD SERVICE |
| Manufacturer Address | * LOS ANGELES CA 90074 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-10-31 |