MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-09 for VERITAS manufactured by Baxter Healthcare Corporation.
[183908156]
Date of event: (b)(6) 2014 to (b)(6) 2016. Elder, e. ? Veritas in immediate implant-based breast reconstruction is associated with higher complications compared with tiloop?. Plast reconstr surg glob open 2019;7: e2533; doi: 10. 1097/ gox. 0000000000002533; published online 31 december 2019. ) should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[183908157]
It was reported that 36 patients experienced post-operative events after implant based breast reconstruction surgeries were performed using veritas over a three-year period. It was reported 19 patients experienced seroma, six patients experienced implant rotation, seven patients experienced localized breast pocket infections and four patients experienced wound breakdowns. It was reported the events required surgical or medical interventions (antibiotics, not further specified). No further detail was provided regarding if hospitalization was required or the patient? S outcome. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-01282 |
| MDR Report Key | 9806475 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-09 |
| 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 Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Street | 2575 UNIVERSITY AVE W |
| Manufacturer City | SAINT PAUL MN 55114 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55114 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERITAS |
| Generic Name | MESH, SURGICAL |
| Product Code | FTM |
| Date Received | 2020-03-09 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-09 |