MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2020-03-13 for GASTROSTOMY TUBE - DUAL ENFIT PORT 70-0062-220 VED-220 manufactured by Xeridiem Medical Devices.
| Report Number | 2025851-2020-00001 |
| MDR Report Key | 9832248 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-06-18 |
| Date Added to Maude | 2020-03-13 |
| 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 | MR. STEVE MURRAY |
| Manufacturer Street | 4700 S. OVERLAND DRIVE |
| Manufacturer City | TUCSON, AZ |
| Manufacturer Country | US |
| Manufacturer Phone | 8827794178 |
| Manufacturer G1 | XERIDIEM MEDICAL DEVICES |
| Manufacturer Street | 4700 S. OVERLAND DRIVE |
| Manufacturer City | TUCSON, AZ |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GASTROSTOMY TUBE - DUAL ENFIT PORT |
| Generic Name | GASTROSTOMY TUBE |
| Product Code | PIF |
| Date Received | 2020-03-13 |
| Returned To Mfg | 2020-02-21 |
| Model Number | 70-0062-220 |
| Catalog Number | VED-220 |
| Lot Number | 1002103 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XERIDIEM MEDICAL DEVICES |
| Manufacturer Address | 4700 S. OVERLAND DRIVE TUCSON, AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-13 |