MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-15 for OSSIX VOLUMAX manufactured by Datum Dental Ltd..
[97308419]
After a week and two weeks after the procedure the patient had inflammation and some swelling in the area. The patient had a history of allergies. The patient was put on cipher; the doctor thinks the patient used her own antibiotics from sweden and thinks they were expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010626093-2018-00001 |
| MDR Report Key | 7189857 |
| Date Received | 2018-01-15 |
| Date of Report | 2018-01-15 |
| Date Mfgr Received | 2017-12-22 |
| Date Added to Maude | 2018-01-15 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. ARIE GOLDLUST |
| Manufacturer Street | 1 BAT SHEVA ST. |
| Manufacturer City | LOD, 7120101 |
| Manufacturer Country | IS |
| Manufacturer Postal | 7120101 |
| Manufacturer G1 | DATUM DENTAL LTD. |
| Manufacturer Street | 1 BAT SHEVA ST. |
| Manufacturer City | LOD, 7120101 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 7120101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OSSIX VOLUMAX |
| Generic Name | RESORBABLE COLLAGEN MEMBRANE |
| Product Code | NPL |
| Date Received | 2018-01-15 |
| Operator | DENTIST |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATUM DENTAL LTD. |
| Manufacturer Address | 1, BAT SHEVA ST. LOD, 7120101 IS 7120101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2018-01-15 |