MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2017-10-18 for CERASORB DENTAL UNKNOWN manufactured by Curasan Ag.
[89567536]
The data from the med watch report mw5066910 does not match. Event date 2010, reported 2016 and planned for 2003. Also in a non-approved application. On further request of medical background was not replied. The complaint was rejected.
Patient Sequence No: 1, Text Type: N, H10
[89567537]
The patient complaint that the drs. Has implemented cerasorb dental and organic plastics in lumbar spine fusion and back muscles and damaged at the treatment several nerves
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004847139-2017-00001 |
| MDR Report Key | 6957322 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2017-10-18 |
| Date of Report | 2017-10-16 |
| Date of Event | 2010-09-09 |
| Date Mfgr Received | 2017-02-07 |
| Date Added to Maude | 2017-10-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DIRK B |
| Manufacturer Street | LINDIGSTR. 4 |
| Manufacturer City | KLEINOSTHEIM, BAYERN 63801 |
| Manufacturer Country | GM |
| Manufacturer Postal | 63801 |
| Manufacturer G1 | CURASAN AG |
| Manufacturer Street | LINDIGSTR. 4 |
| Manufacturer City | KLEINOSTHEIM, BAYERN 63801 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 63801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERASORB DENTAL |
| Generic Name | CERASORB DENTAL |
| Product Code | LYC |
| Date Received | 2017-10-18 |
| Model Number | CERASORB |
| Catalog Number | UNKNOWN |
| Lot Number | UNKONWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CURASAN AG |
| Manufacturer Address | ERNST-WISS-STR. 18 FRANKFURT / MAIN, HESSEN 65933 GM 65933 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-18 |