MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-09-19 for PHASIX ST MESH UNKAA110 manufactured by Tepha, Inc.
Report Number | 1213643-2019-09031 |
MDR Report Key | 9090175 |
Report Source | CONSUMER,OTHER |
Date Received | 2019-09-19 |
Date of Report | 2019-09-19 |
Date Mfgr Received | 2019-08-30 |
Date Added to Maude | 2019-09-19 |
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 | JAN LING |
Manufacturer Street | 100 CROSSINGS BLVD. |
Manufacturer City | WARWICK RI 02886 |
Manufacturer Country | US |
Manufacturer Postal | 02886 |
Manufacturer Phone | 8015652300 |
Manufacturer G1 | BARD SHANNON LIMITED 3005636544 |
Manufacturer Street | SAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7 |
Manufacturer City | HUMACAO PR 00791 |
Manufacturer Country | US |
Manufacturer Postal Code | 00791 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PHASIX ST MESH |
Generic Name | SURGICAL MESH |
Product Code | OWT |
Date Received | 2019-09-19 |
Model Number | NA |
Catalog Number | UNKAA110 |
Lot Number | NI |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TEPHA, INC |
Manufacturer Address | 99 HAYDEN AVENUE EAST WING, SUITE 360 LEXINGTON MA 02421 US 02421 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-09-19 |