MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-08-19 for ACCESSORIES UNIVERSAL 100323C0 - RADIAL SETTING CLAMP 100323C0 manufactured by Holger Ullrich.
| Report Number | 3013876692-2019-00014 |
| MDR Report Key | 8907221 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-19 |
| Date of Report | 2019-11-15 |
| Date of Event | 2019-08-08 |
| Date Facility Aware | 2019-11-13 |
| Report Date | 2019-11-15 |
| Date Reported to FDA | 2019-11-15 |
| Date Reported to Mfgr | 2019-11-15 |
| Date Added to Maude | 2019-08-19 |
| Event Key | 0 |
| Report Source Code | Distributor 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 |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer G1 | MAQUET MEDICAL SYSTEMS, USA |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCESSORIES UNIVERSAL |
| Generic Name | TABLE AND ATTACHMENTS, OPERATING-ROOM |
| Product Code | BWN |
| Date Received | 2019-08-19 |
| Model Number | 100323C0 - RADIAL SETTING CLAMP |
| Catalog Number | 100323C0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLGER ULLRICH |
| Manufacturer Address | MAQUET GMBH KEHLER STRASSE 31, RASTATT 76437 GM 76437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-19 |