MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-04 for PREVANTICS DYNDC2395A manufactured by Pdi/nice-pak Products, Inc..
| Report Number | 1417592-2019-00154 |
| MDR Report Key | 8960014 |
| Date Received | 2019-09-04 |
| Date of Report | 2019-09-20 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2019-08-08 |
| Date Added to Maude | 2019-09-04 |
| 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 | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PREVANTICS |
| Generic Name | SWAB STICK IN DRESSING CHANGE TRAY |
| Product Code | MCY |
| Date Received | 2019-09-04 |
| Catalog Number | DYNDC2395A |
| Lot Number | 18FBR284 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PDI/NICE-PAK PRODUCTS, INC. |
| Manufacturer Address | 400 CHESTNUT RIDGE ROAD WOODCLIFF LAKE NJ 07677 US 07677 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-04 |