MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-10-31 for ENDO CATCH II 173049 manufactured by Davis & Geck Caribe Ltd.
| Report Number | 9612501-2019-02105 |
| MDR Report Key | 9263839 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-10-31 |
| Date of Report | 2019-10-31 |
| Date of Event | 2019-09-05 |
| Date Mfgr Received | 2019-10-28 |
| Device Manufacturer Date | 2019-03-22 |
| Date Added to Maude | 2019-10-31 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | DAVIS & GECK CARIBE LTD |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO |
| Manufacturer City | SANTO DOMINGO 18750 |
| Manufacturer Country | DO |
| Manufacturer Postal Code | 18750 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO CATCH II |
| Generic Name | LARYNGOSCOPE, ENDOSCOPE |
| Product Code | GCI |
| Date Received | 2019-10-31 |
| Returned To Mfg | 2019-10-16 |
| Model Number | 173049 |
| Catalog Number | 173049 |
| Lot Number | J9C2293HY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVIS & GECK CARIBE LTD |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO SANTO DOMINGO 18750 DO 18750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-31 |