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 2019-04-12 for MAK-NV INTRODUCER SYSTEM K12-MAKNVF1/JP manufactured by Merit Medical Systems Inc..
[141765436]
The device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[141765437]
The account alleges that during a biliary drainage tube placement procedure, the radiopaque marker band had detached. A ct exam confirmed that the marker band had migrated into the patient's intestinal tract. No intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721504-2019-00026 |
| MDR Report Key | 8508884 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-12 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-03-13 |
| Date Mfgr Received | 2019-06-24 |
| Device Manufacturer Date | 2018-05-02 |
| Date Added to Maude | 2019-04-12 |
| 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 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012531600 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS INC. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN, UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84095 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAK-NV INTRODUCER SYSTEM |
| Generic Name | INTRODUCER SYSTEM |
| Product Code | OEQ |
| Date Received | 2019-04-12 |
| Returned To Mfg | 2019-04-23 |
| Catalog Number | K12-MAKNVF1/JP |
| Lot Number | H1342430 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS INC. |
| Manufacturer Address | 1600 MERIT PARKWAY SOUTH JORDAN, UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-12 |