MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-07-26 for HIGH PRESSURE TUBING HP9481E/A manufactured by Merit Medical Systems, Inc..
| Report Number | 3011642792-2019-00014 |
| MDR Report Key | 8831558 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-07-26 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-04-04 |
| Date Mfgr Received | 2019-06-14 |
| Device Manufacturer Date | 2019-02-06 |
| Date Added to Maude | 2019-07-26 |
| 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 | MRS. KATIE SWENSON, CQE, CBA, CQPA |
| Manufacturer Street | 1600 W MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012081600 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Street | AVENIDO SOR JUANA INES DE LA C #19970-B |
| Manufacturer City | TIJUANA, |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGH PRESSURE TUBING |
| Generic Name | HIGH PRESSURE TUBING |
| Product Code | DXJ |
| Date Received | 2019-07-26 |
| Returned To Mfg | 2019-04-30 |
| Catalog Number | HP9481E/A |
| Lot Number | I1513040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS, INC. |
| Manufacturer Address | AVENIDO SOR JUANA INES DE LA C #19970-B TIJUANA, MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-26 |