MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-18 for SFX SYM PDS+ UNI VIO 18IN 1 S/A CT-1 SXPP1A404 manufactured by Ethicon Inc..
Report Number | 2210968-2020-02189 |
MDR Report Key | 9847692 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-03-18 |
Date of Report | 2020-02-25 |
Date of Event | 2020-02-25 |
Date Mfgr Received | 2020-03-20 |
Device Manufacturer Date | 2019-06-12 |
Date Added to Maude | 2020-03-18 |
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 | KARA DITTY-BOVARD |
Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
Manufacturer City | SOMERVILLE NJ 08876 |
Manufacturer Country | US |
Manufacturer Postal | 08876 |
Manufacturer Phone | 6107428552 |
Manufacturer G1 | ETHICON INC.-JUAREZ |
Manufacturer Street | AVENIDA DE LAS TORRES 7125 COL SALVACAR |
Manufacturer City | CUIDAD JUAREZ 32604 |
Manufacturer Country | MX |
Manufacturer Postal Code | 32604 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SFX SYM PDS+ UNI VIO 18IN 1 S/A CT-1 |
Generic Name | SUTURE, SURGICAL, ABSORBABLE |
Product Code | NEW |
Date Received | 2020-03-18 |
Returned To Mfg | 2020-03-11 |
Model Number | SXPP1A404 |
Catalog Number | SXPP1A404 |
Lot Number | PGZ598 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ETHICON INC. |
Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-18 |