MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-25 for BARRICAID ANNULAR CLOSURE DEVICE 2730815-A8 manufactured by Intrinsic Therapeutics.
Report Number | 3006232063-2020-00001 |
MDR Report Key | 9881200 |
Report Source | COMPANY REPRESENTATIVE |
Date Received | 2020-03-25 |
Date of Report | 2020-03-25 |
Date of Event | 2020-02-27 |
Date Mfgr Received | 2020-03-04 |
Device Manufacturer Date | 2019-04-26 |
Date Added to Maude | 2020-03-25 |
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 | MR. SAMIR PALIWAL |
Manufacturer Street | 30 COMMERCE WAY |
Manufacturer City | WOBURN, MA |
Manufacturer Country | US |
Manufacturer Phone | 9320222117 |
Manufacturer G1 | INTRINSIC THERAPEUTICS |
Manufacturer Street | 30 COMMERCE WAY |
Manufacturer City | WOBURN, MA |
Manufacturer Country | US |
Single Use | 3 |
Remedial Action | OT |
Previous Use Code | 3 |
Removal Correction Number | N/A |
Event Type | 3 |
Type of Report | 3 |
Brand Name | BARRICAID ANNULAR CLOSURE DEVICE |
Generic Name | BARRICAID |
Product Code | QES |
Date Received | 2020-03-25 |
Returned To Mfg | 2020-03-04 |
Model Number | 2730815-A8 |
Lot Number | 04191901 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | 10 MO |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | INTRINSIC THERAPEUTICS |
Manufacturer Address | 30 COMMERCE WAY WOBURN, MA US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2020-03-25 |