MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-07-25 for ENTUIT LP GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT 70-0061-614 LP-SBRD-14-3.5-ENF manufactured by Xeridiem Medical Devices.
| Report Number | 2025851-2019-00005 |
| MDR Report Key | 8828565 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-07-25 |
| Date of Report | 2019-07-11 |
| Date of Event | 2019-06-28 |
| Date Mfgr Received | 2019-07-11 |
| Date Added to Maude | 2019-07-25 |
| 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 857143430 |
| Manufacturer Country | US |
| Manufacturer Postal | 857143430 |
| Manufacturer Phone | 5208827794 |
| Manufacturer G1 | XERIDIEM MEDICAL DEVICES |
| Manufacturer Street | 4700 S. OVERLAND DRIVE |
| Manufacturer City | TUCSON AZ 857143430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 857143430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTUIT LP GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT |
| Generic Name | GASTROSTOMY TUBE |
| Product Code | PIF |
| Date Received | 2019-07-25 |
| Model Number | 70-0061-614 |
| Catalog Number | LP-SBRD-14-3.5-ENF |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XERIDIEM MEDICAL DEVICES |
| Manufacturer Address | 4700 S. OVERLAND DRIVE TUCSON, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-07-25 |