MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-06 for OMNIOPORE SURGICAL IMPLANT UNKNOWN manufactured by Matrix Surgical Usa.
[135339349]
During this investigation, no further product or patient information have been reported. The device identification is unknown; 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. Matrix surgical responded via email with 3 attempts from (b)(4) 2019 thru to distributor contact, (b)(6), to gain more information related to the event and the product in use. No response was received. If additional information is received, it will be provided in a supplemental report. No information or device were received for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[135339350]
Phone call message was received from our distributor (b)(6) on the evening of (b)(6) 2019 indicated that their customer a physician had a patient with an infection after placement of a chin implant. It was shared that the infection duration was about 2 months and the patient was being treated with antibiotics. No other information was received at the time of this initial contact. Matrix surgical responded via email on (b)(4) 2019 to distributor contact, (b)(6), to gain more information related to the event and the product in use. Adverse event investigation - infection form was provided as an attachment. No response was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009383407-2019-00001 |
| MDR Report Key | 8312585 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-06 |
| Date of Report | 2019-02-06 |
| Date of Event | 2019-01-08 |
| Date Mfgr Received | 2019-01-09 |
| Date Added to Maude | 2019-02-06 |
| 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 | 4025 WELCOME ALL ROAD SUITE 120 |
| Manufacturer City | ATLANTA 303491879 |
| Manufacturer Country | US |
| Manufacturer Postal | 303491879 |
| Manufacturer Phone | 9513260131 |
| Manufacturer G1 | MATRIX SURGICAL USA |
| Manufacturer Street | 4025 WELCOME ALL ROAD SUITE 120 |
| Manufacturer City | ATLANTA GA 303491879 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 303491879 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNIOPORE SURGICAL IMPLANT |
| Generic Name | HDPE FACIAL IMPLANT |
| Product Code | KKY |
| Date Received | 2019-02-06 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| 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 | 2019-02-06 |