MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-07-12 for OSSIX VOLUMAX manufactured by Datum Dental Ltd..
[113867586]
The patient reportedly had exposed threads on implants 4 and 5, the doctor used ossix volumax to provide connective tissue covering of the implants on (b)(6) 2018. The patient called on (b)(6) 2018 with a complaint of bruising around her right eye, neck, chin down to her chest. Doctor indicated this is not uncommon in elderly and that it was a minimal surgery in terms of duration and incision. The patient was seen on (b)(6) 2018. Patient had dark swelling by the right eye. The doctor removed the sutures and thick black pieces with a consistency 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 was resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010626093-2018-00002 |
| MDR Report Key | 7684398 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-07-12 |
| Date of Report | 2018-07-12 |
| Date of Event | 2018-05-30 |
| Date Mfgr Received | 2018-06-15 |
| Date Added to Maude | 2018-07-12 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. ARIE GOLDLUST |
| Manufacturer Street | 1 BAT SHEVA ST., POBOX 6170 |
| Manufacturer City | LOD, 7116003 |
| Manufacturer Country | IS |
| Manufacturer Postal | 7116003 |
| Manufacturer G1 | DATUM DENTAL LTD. |
| Manufacturer Street | 1 BAT SHEVA ST., POBOX 6170 |
| Manufacturer City | LOD 7116003 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 7116003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSSIX VOLUMAX |
| Generic Name | RESORBABLE COLLAGEN MEMBRANE |
| Product Code | NPL |
| Date Received | 2018-07-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATUM DENTAL LTD. |
| Manufacturer Address | 1 BAT SHEVA ST., P.O.BOX 6170 LOD, 7116003 IS 7116003 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-12 |