MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for LINA BIPOLAR LOOP BL-160 manufactured by Lina Medical Aps.
[123518262]
The defective devices has not been returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[123518263]
Allegedly, 2ea bl-160 broke during surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007699067-2018-00001 |
| MDR Report Key | 7937740 |
| Date Received | 2018-10-05 |
| Date of Report | 2018-10-05 |
| Date of Event | 2017-03-20 |
| Date Facility Aware | 2017-03-20 |
| Report Date | 2017-04-04 |
| Date Reported to FDA | 2017-04-04 |
| Date Mfgr Received | 2018-04-12 |
| Device Manufacturer Date | 2014-09-17 |
| Date Added to Maude | 2018-10-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MS MONIKA LEWANDOWSKA |
| Manufacturer Street | FORMERVANGEN 5 |
| Manufacturer City | GLOSTRUP, DK2600 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK2600 |
| Manufacturer G1 | LINA MEDICAL POLSKA SP. Z O.O. |
| Manufacturer Street | ROLNA 8A SADY |
| Manufacturer City | TARNOWO PODG 62-080 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LINA BIPOLAR LOOP |
| Generic Name | LINA BIPOLAR LOOP, SMALL |
| Product Code | HIN |
| Date Received | 2018-10-05 |
| Model Number | BL-160 |
| Catalog Number | BL-160 |
| Lot Number | 14351 |
| Device Expiration Date | 2019-04-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINA MEDICAL APS |
| Manufacturer Address | FORMERVANGEN 5 DENMARK, GLOSTRUP DK2600 DA DK2600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 2018-10-05 |