MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-10 for RHEIN MEDICAL 08-14527 manufactured by Katena Products, Inc.
| Report Number | 2242450-2019-00001 |
| MDR Report Key | 9176998 |
| Date Received | 2019-10-10 |
| Date of Report | 2019-10-10 |
| Date of Event | 2019-05-31 |
| Date Facility Aware | 2019-06-07 |
| Date Mfgr Received | 2019-06-04 |
| Date Added to Maude | 2019-10-10 |
| 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 | BRYAN WEINMANN |
| Manufacturer Street | 6 CAMPUS DRIVE, SUITE 310 |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9739573509 |
| Manufacturer G1 | KATENA PRODUCTS, INC |
| Manufacturer Street | 6 CAMPUS DRIVE, SUITE 310 |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RHEIN MEDICAL |
| Generic Name | SHEPPARD TOMAHAWK CHOPPER RIGHT HAND DOMINANT |
| Product Code | HND |
| Date Received | 2019-10-10 |
| Returned To Mfg | 2019-06-27 |
| Model Number | 08-14527 |
| Catalog Number | 08-14527 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KATENA PRODUCTS, INC |
| Manufacturer Address | 6 CAMPUS DRIVE, SUITE 310 PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-10 |