MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-12 for COVIDIEN LF1837CRH manufactured by Medline Renewal.
Report Number | 3032391-2019-00020 |
MDR Report Key | 9010461 |
Date Received | 2019-09-12 |
Date of Report | 2019-09-12 |
Date of Event | 2019-08-15 |
Date Mfgr Received | 2019-08-15 |
Date Added to Maude | 2019-09-12 |
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 | STEPHEN WILSON |
Manufacturer Street | 1500 NE HEMLOCK AVE |
Manufacturer City | REDMOND OR 97756 |
Manufacturer Country | US |
Manufacturer Postal | 97756 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | COVIDIEN |
Generic Name | LIGASURE BLUNT TIP, SEALER/DIVIDER, NANO-COATED, COMPATIBLE WITH FT10 GENERATOR |
Product Code | NUJ |
Date Received | 2019-09-12 |
Returned To Mfg | 2019-08-19 |
Catalog Number | LF1837CRH |
Lot Number | UNK |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDLINE RENEWAL |
Manufacturer Address | 1500 NE HEMLOCK AVE REDMOND OR 97756 US 97756 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-09-12 |