MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-15 for KENDALL VERSALON 9025 manufactured by Covidien.
| Report Number | 1047429-2019-00005 |
| MDR Report Key | 8514297 |
| Date Received | 2019-04-15 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-03-05 |
| Date Mfgr Received | 2019-03-18 |
| Date Added to Maude | 2019-04-15 |
| 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 | MS. NICHOLE EARLY |
| Manufacturer Street | 9000 WESTMONT DRIVE |
| Manufacturer City | TOANO VA 23168 |
| Manufacturer Country | US |
| Manufacturer Postal | 23168 |
| Manufacturer Phone | 8283387568 |
| Manufacturer G1 | AVID MEDICAL INC. |
| Manufacturer Street | 9000 WESTMONT DRIVE |
| Manufacturer City | TOANO VA 23168 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 23168 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KENDALL VERSALON |
| Generic Name | NONWOVEN ALL-PURPOSE SPONGE |
| Product Code | NAB |
| Date Received | 2019-04-15 |
| Catalog Number | 9025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1430 MARVIN GRIFFIN RD AUGUSTA GA 30906 US 30906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-15 |