MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-08 for LINA GOLD LOOP EL-200-8 manufactured by Lina Medical Aps.
[92599218]
The defective device has not been returned to manufacturer, lot number of this unit is not known as well.
Patient Sequence No: 1, Text Type: N, H10
[92599219]
Lina loop broke as it was in use. The "stray" end cut through tissue as it was pulled through. Also, a vessel was cut which resulted in excessive bleeding. This required a emergent call to a surgeon for repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007699067-2017-00006 |
| MDR Report Key | 7008775 |
| Date Received | 2017-11-08 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-09-25 |
| Report Date | 2017-10-23 |
| Date Reported to Mfgr | 2017-10-23 |
| Date Mfgr Received | 2017-10-18 |
| Date Added to Maude | 2017-11-08 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JOANNA MAZUR |
| Manufacturer Street | FORMERVANGEN 5 DK-2600 GLOSTRUP |
| Manufacturer City | GLOSTRUP, |
| Manufacturer Country | DA |
| Manufacturer G1 | LINA MEDICAL POLSKA SP. Z O. O. |
| Manufacturer Street | ROLNA 8A, SADY TARNOWO PODG |
| Manufacturer City | SADY, 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 GOLD LOOP |
| Generic Name | LINA GOLD LOOP |
| Product Code | KNF |
| Date Received | 2017-11-08 |
| Model Number | EL-200-8 |
| Catalog Number | EL-200-8 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINA MEDICAL APS |
| Manufacturer Address | FORMERVANGEN 5 GLOSTRUP, DK2600 DA DK2600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-11-08 |