MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-23 for D 860 - CFK - POLYMER OT 8602075 manufactured by Berchtold Gmbh & Co. Kg.
Report Number | 0008010153-2020-00003 |
MDR Report Key | 9868276 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2020-03-23 |
Date of Report | 2020-03-23 |
Date of Event | 2017-08-31 |
Date Mfgr Received | 2020-03-05 |
Date Added to Maude | 2020-03-23 |
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 |
Reporter Occupation | BIOMEDICAL ENGINEER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. VOLKER HORNSCHEIDT |
Manufacturer Street | LUDWIGSTALER STRASSE 25 |
Manufacturer City | TUTTLINGEN 78532 |
Manufacturer Country | DE |
Manufacturer Postal | 78532 |
Manufacturer Phone | 74611810 |
Manufacturer G1 | BERCHTOLD GMBH & CO. KG |
Manufacturer Street | LUDWIGSTALER STRASSE 25 |
Manufacturer City | TUTTLINGEN 78532 |
Manufacturer Country | DE |
Manufacturer Postal Code | 78532 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | D 860 - CFK - POLYMER |
Generic Name | TABLE, OPERATING-ROOM, ELECTRICAL |
Product Code | GDC |
Date Received | 2020-03-23 |
Catalog Number | OT 8602075 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BERCHTOLD GMBH & CO. KG |
Manufacturer Address | LUDWIGSTALER STRASSE 25 TUTTLINGEN 78532 DE 78532 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-23 |