MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-07-09 for XENMATRIX AB 1150606 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
Report Number | 1213643-2019-05855 |
MDR Report Key | 8771008 |
Report Source | COMPANY REPRESENTATIVE,USER F |
Date Received | 2019-07-09 |
Date of Report | 2019-07-09 |
Date Mfgr Received | 2019-06-17 |
Device Manufacturer Date | 2019-06-07 |
Date Added to Maude | 2019-07-09 |
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 | LAURA SUNDBERG |
Manufacturer Street | 100 CROSSINGS BLVD. |
Manufacturer City | WARWICK RI 02886 |
Manufacturer Country | US |
Manufacturer Postal | 02886 |
Manufacturer Phone | 4018258462 |
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 | XENMATRIX AB |
Generic Name | PORCINE SURGICAL MESH |
Product Code | PIJ |
Date Received | 2019-07-09 |
Model Number | NA |
Catalog Number | 1150606 |
Lot Number | HUCW1444 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | DAVOL INC., SUB. C.R. BARD, INC. |
Manufacturer Address | 100 CROSSINGS BLVD. WARWICK RI 02886 US 02886 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-07-09 |