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 2020-02-06 for TEMNO NEEDLE BIOPSY ACT2215 manufactured by Merit Medical Systems Inc..
[186544012]
The suspect device was not returned for evaluation. The complaint could not be confirmed. The root cause could not be determined. A search of the complaint database was performed and no similar complaints for this lot number were found. The device history record was reviewed and no exception documents were found.
Patient Sequence No: 1, Text Type: N, H10
[186544013]
Account alleges that a patient was undergoing an image guided biopsy procedure via ct scan of the upper lobe within the left lung. A post procedure chest x-ray demonstrated 2 tiny foreign objects at the medial border of a nodule within the patient's lung.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721504-2020-00005 |
| MDR Report Key | 9679236 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-06 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-11-27 |
| Date Mfgr Received | 2020-01-07 |
| 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 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 | TEMNO NEEDLE BIOPSY |
| Generic Name | BIOPSY NEEDLE |
| Product Code | FCG |
| Date Received | 2020-02-06 |
| Catalog Number | ACT2215 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-06 |