MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-13 for CHROMOPHARE OR LIGHT CEILING-MOUNTED CH00000001 manufactured by Berchtold Gmbh & Co. Kg.
| Report Number | 0008010153-2020-00002 |
| MDR Report Key | 9829501 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-13 |
| 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 |
| Removal Correction Number | RES 83355 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMOPHARE OR LIGHT CEILING-MOUNTED |
| Generic Name | LIGHT, SURGICAL, CEILING MOUNTED |
| Product Code | FSY |
| Date Received | 2020-03-13 |
| Model Number | CH00000001 |
| Catalog Number | CH00000001 |
| 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 | 2020-03-13 |