MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for SURGITIE AUTOSUTURE LIGATING LOOP WITH DELIVERY SYSTEM EL-21-L manufactured by Covidien.
[183908229]
The device would not deploy.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9847725 |
MDR Report Key | 9847725 |
Date Received | 2020-03-18 |
Date of Report | 2020-02-26 |
Date of Event | 2020-02-26 |
Report Date | 2020-02-26 |
Date Reported to FDA | 2020-02-26 |
Date Reported to Mfgr | 2020-03-18 |
Date Added to Maude | 2020-03-18 |
Event Key | 0 |
Report Source Code | User Facility 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 | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SURGITIE AUTOSUTURE LIGATING LOOP WITH DELIVERY SYSTEM |
Generic Name | SUTURE, ABSORBABLE, NATURAL |
Product Code | GAL |
Date Received | 2020-03-18 |
Model Number | EL-21-L |
Catalog Number | EL-21-L |
Lot Number | J9J1828Y |
Device Availability | Y |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | COVIDIEN |
Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-18 |