MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-10-25 for C-ARMOR 5523 manufactured by .
| Report Number | 2182318-2019-00004 |
| MDR Report Key | 9242465 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-10-25 |
| Date of Report | 2019-05-28 |
| Date Mfgr Received | 2019-04-29 |
| Device Manufacturer Date | 2018-12-13 |
| Date Added to Maude | 2019-10-25 |
| 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 | CHRIS RAHN |
| Manufacturer Street | 570 ENTERPRISE DRIVE |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207514300 |
| Manufacturer G1 | TIDI PRODUCTS LLC |
| Manufacturer Street | 570 ENTERPRISE DRIVE |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 54956 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C-ARMOR |
| Generic Name | C-ARM EQUIPMENT COVERS |
| Product Code | KKX |
| Date Received | 2019-10-25 |
| Model Number | 5523 |
| Catalog Number | 5523 |
| Lot Number | LOT #012454 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-25 |