MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-01 for BERCHTOLD OPERON D860 D 860 manufactured by Stryker Communications Inc..
Report Number | MW5087733 |
MDR Report Key | 8749837 |
Date Received | 2019-07-01 |
Date of Report | 2019-06-19 |
Date of Event | 2019-05-29 |
Date Added to Maude | 2019-07-01 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | BERCHTOLD OPERON D860 |
Generic Name | TABLE, OPERATING ROOM, ELECTRICAL |
Product Code | GDC |
Date Received | 2019-07-01 |
Model Number | D 860 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | STRYKER COMMUNICATIONS INC. |
Manufacturer Address | FLOWER MOUND TX US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-07-01 |