MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-17 for 1.55MM X 10MM TWIST DR,S S-1510TD-G1 manufactured by Depuy Synthes Products Llc.
| Report Number | 1045834-2019-53834 |
| MDR Report Key | 8704226 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-06-17 |
| Date of Report | 2019-06-05 |
| Date of Event | 2019-06-04 |
| Date Mfgr Received | 2019-08-01 |
| Device Manufacturer Date | 2018-05-25 |
| Date Added to Maude | 2019-06-17 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.55MM X 10MM TWIST DR,S |
| Generic Name | BUR, SURGICAL, GENERAL & PLASTIC SURGERY - CUTTING BURR |
| Product Code | GFF |
| Date Received | 2019-06-17 |
| Returned To Mfg | 2019-07-15 |
| Catalog Number | S-1510TD-G1 |
| Lot Number | M163130963 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Address | 4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-17 |