MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-06 for INFLATION DEVICE.BASIXCOMPAK? IN4130/D manufactured by Merit Medical Ireland Ltd.
| Report Number | 9616622-2020-00001 |
| MDR Report Key | 9679234 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-12-31 |
| Date Mfgr Received | 2020-01-03 |
| Device Manufacturer Date | 2019-08-06 |
| Date Added to Maude | 2020-02-06 |
| 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 | MR. DAVID LOCKRIDGE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012084551 |
| Manufacturer G1 | MERIT MEDICAL IRELAND LTD |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST BALLYBRIT |
| Manufacturer City | GALWAY, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFLATION DEVICE.BASIXCOMPAK? |
| Generic Name | INFLATION DEVICE |
| Product Code | MAV |
| Date Received | 2020-02-06 |
| Returned To Mfg | 2020-02-12 |
| Catalog Number | IN4130/D |
| Lot Number | K1632839 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL IRELAND LTD |
| Manufacturer Address | PARKMORE BUSINESS PARK WEST BALLYBRIT GALWAY, EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |