MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-06 for ESOPHAGEAL STETHOSCOPE, 12 FRENCH 81-040412 manufactured by Deroyal Cientifica De Latinoamerica S.r.l..
| Report Number | 9613793-2019-00004 |
| MDR Report Key | 9284261 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-11-06 |
| Date of Report | 2019-11-06 |
| Date of Event | 2019-10-07 |
| Date Mfgr Received | 2019-10-14 |
| Date Added to Maude | 2019-11-06 |
| 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 | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. |
| Manufacturer Street | GLOBAL PARK BOX 180-3006, 602 PARKWAY |
| Manufacturer City | LA AURORA, HEREDIA, HEREDIA 146 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 146 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESOPHAGEAL STETHOSCOPE, 12 FRENCH |
| Generic Name | STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS |
| Product Code | BZT |
| Date Received | 2019-11-06 |
| Returned To Mfg | 2019-10-17 |
| Model Number | 81-040412 |
| Lot Number | 49586751 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. |
| Manufacturer Address | GLOBAL PARK BOX 180-3006, 602 PARKWAY LA AURORA, HEREDIA, HEREDIA 146 CS 146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-06 |