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 |