MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-15 for GUT CHR UD 27IN 4-0 S/A FS-2 635H manufactured by Ethicon Inc..
| Report Number | 2210968-2019-89969 |
| MDR Report Key | 9329952 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-11-15 |
| Date of Report | 2019-10-25 |
| Date Mfgr Received | 2019-10-25 |
| Device Manufacturer Date | 2019-06-03 |
| Date Added to Maude | 2019-11-15 |
| 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 | CIUDAD 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 | GUT CHR UD 27IN 4-0 S/A FS-2 |
| Generic Name | SUTURE, ABSORBABLE, NATURAL |
| Product Code | GAL |
| Date Received | 2019-11-15 |
| Returned To Mfg | 2019-11-13 |
| Catalog Number | 635H |
| Lot Number | PGM313 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-11-15 |