MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-07-02 for 3S HEMI IMPLANT 101-00-00X manufactured by Trilliant Surgical.
| Report Number | 3007420745-2019-00035 |
| MDR Report Key | 8754262 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-07-02 |
| Date of Report | 2019-07-02 |
| Date of Event | 2019-05-20 |
| Date Mfgr Received | 2019-06-04 |
| Date Added to Maude | 2019-07-02 |
| 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 | KAYLEE LUDDEN |
| Manufacturer Street | 727 N SHEPHERD DR STE 100 |
| Manufacturer City | HOUSTON TX 77007 |
| Manufacturer Country | US |
| Manufacturer Postal | 77007 |
| Manufacturer Phone | 8004952919 |
| Manufacturer G1 | TRILLIANT SURGICAL |
| Manufacturer Street | 727 N SHEPHERD DR STE 100 |
| Manufacturer City | HOUSTON TX 77007 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77007 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3S HEMI IMPLANT |
| Generic Name | 3S HEMI IMPLANT |
| Product Code | KWD |
| Date Received | 2019-07-02 |
| Model Number | 101-00-00X |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRILLIANT SURGICAL |
| Manufacturer Address | 727 N SHEPHERD DR STE 100 HOUSTON TX 77007 US 77007 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2019-07-02 |