MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-22 for OMNIPORE SURGICAL IMPLANT OP8322 manufactured by Matrix Surgical Usa.
[136882801]
During this investigation no further product or patient information have been reported. The device will not be available for testing; therefore, no product deficiency can be evaluated. There is the possibility that clinical factors may have contributed to this event. At this time the cause of the infection is unknown. Based on the lack of information received, the cause of the reported incident could not be determined. No information or device were received for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[136882802]
Phone call message was received by (b)(6) (vp marketing) on (b)(6) 2019 from surgeon reporting that a patient had developed a post-operative infection after the implantation of the two-piece chin. No other information was received at the time of this initial contact. Product information was made available by the review of distribution records.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009383407-2019-00004 |
| MDR Report Key | 8362264 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-22 |
| Date of Report | 2019-02-22 |
| Date Mfgr Received | 2019-01-29 |
| Device Manufacturer Date | 2017-06-01 |
| Date Added to Maude | 2019-02-22 |
| 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 | MS. VICKI CLOUTIER |
| Manufacturer Street | WELCOME ALL ROAD SUITE 120 |
| Manufacturer City | ATLANTA GA 303491879 |
| Manufacturer Country | US |
| Manufacturer Postal | 303491879 |
| Manufacturer Phone | 4048554592 |
| Manufacturer G1 | MATRIX SURGICAL USA |
| Manufacturer Street | 4025 WELCOME ALL ROAD SUITE 120 |
| Manufacturer City | ATLANTA 303491879 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 303491879 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNIPORE SURGICAL IMPLANT |
| Generic Name | HDPE FACIAL IMPLANT - TWO-PIECE CHIN - LARGE |
| Product Code | KKY |
| Date Received | 2019-02-22 |
| Model Number | OP8322 |
| Catalog Number | OP8322 |
| Lot Number | 015050617 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MATRIX SURGICAL USA |
| Manufacturer Address | 4025 WELCOME ALL ROAD SUITE 120 ATLANTA GA 303491879 US 303491879 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-22 |