MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-11 for OSSIX VOLUMAX manufactured by Datum Dental Ltd.
[113742119]
It was reported that a patient the patient called the physician one day post-procedure with a complaint of bruising around the right eye, neck, chin down to the chest. Subsequently, on (b)(6) 2018 the patient experienced clots in the area where volumax was administered, the patient's face was swollen, black and blue. The physician indicated that this reaction is not uncommon in elderly patients and the surgery was minimal in terms of duration and incision. The physician removed the sutures and thick black pieces with a consistency of jelly came out along with the ossix volumax. Area was cleaned out and re-sutured. Patient returned on (b)(6) 2018 for observation and the swelling and bruising had resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009443653-2018-00015 |
| MDR Report Key | 7679808 |
| Date Received | 2018-07-11 |
| Date of Report | 2018-06-14 |
| Date of Event | 2018-05-30 |
| Date Facility Aware | 2018-06-14 |
| Report Date | 2018-07-11 |
| Date Reported to FDA | 2018-07-11 |
| Date Reported to Mfgr | 2018-07-11 |
| Date Added to Maude | 2018-07-11 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSSIX VOLUMAX |
| Generic Name | BARRIER, ANIMAL SOURCE, INTRAORAL |
| Product Code | NPL |
| Date Received | 2018-07-11 |
| Model Number | OSSIX VOLUMAX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATUM DENTAL LTD |
| Manufacturer Address | 1 BAT SHEVA STREET P.O. BOX 6170 LOD 7116003 IS 7116003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-11 |