MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-19 for LINA GOLD LOOP (FOR LAPAROSCOPIC) EL-200-8 manufactured by Lina Medical U.s..
[22265695]
Lina gold loop for laparoscopic use, broke as the surgeon was beginning to use it. Replacement given to surgeon which worked appropriately. Mfr; please note that we do not send products to the mfr, but you may arrange for pick-up by calling my number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034639 |
| MDR Report Key | 3642725 |
| Date Received | 2014-02-19 |
| Date of Report | 2014-02-11 |
| Date of Event | 2014-02-02 |
| Date Added to Maude | 2014-02-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINA GOLD LOOP (FOR LAPAROSCOPIC) |
| Generic Name | NONE |
| Product Code | HIN |
| Date Received | 2014-02-19 |
| Model Number | EL-200-8 |
| Lot Number | 13161 |
| Device Expiration Date | 2016-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINA MEDICAL U.S. |
| Manufacturer Address | 1856 CORPORATE DRIVE STE 135 NORCROSS GA 30093 US 30093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-19 |