MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-17 for CERASORB M S05-M1000 manufactured by Curasan Ag.
[117565017]
Patient had an allergic reaction to cerasorb m dental bone graft within a couple of days after putting in the bone graft. Patient experienced redness on her cheeks, feeling ill, and her face swelling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007887347-2018-00001 |
| MDR Report Key | 7794251 |
| Date Received | 2018-08-17 |
| Date of Report | 2018-07-17 |
| Date of Event | 2017-07-13 |
| Date Facility Aware | 2018-05-04 |
| Report Date | 2018-08-16 |
| Date Reported to FDA | 2018-08-16 |
| Date Reported to Mfgr | 2018-05-14 |
| Date Added to Maude | 2018-08-17 |
| 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 |
| Reporter Occupation | DENTIST |
| 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 | 3 |
| Brand Name | CERASORB M |
| Generic Name | BONE GRAFTING MATERIAL |
| Product Code | LYC |
| Date Received | 2018-08-17 |
| Model Number | CERASORB M |
| Catalog Number | S05-M1000 |
| Lot Number | C136D |
| Device Expiration Date | 2019-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CURASAN AG |
| Manufacturer Address | LINDIGSTRASSE 4 KLEINOSTHEIM BAYERN, 63801 GM 63801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-17 |