MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-19 for MAQUET FEMUR HOOK WITH SUPPORT ARM 1433.42A0 1433.420A0 manufactured by Maquet Gmbh.
[4227637]
Customer reported to maquet clinical specialist that a scrub technician cut themselves on the insert of the femoral hook table accessory. No additional details about technician's injury have been provided to maquet. No adverse effects to a pt were reported. (b)(4). Reference mfr report # 8010652-2014-00002.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008355164-2014-00021 |
| MDR Report Key | 3716308 |
| Date Received | 2014-02-19 |
| Date of Report | 2014-01-20 |
| Date Facility Aware | 2014-01-20 |
| Report Date | 2013-02-19 |
| Date Reported to Mfgr | 2014-01-22 |
| Date Added to Maude | 2014-04-02 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 074700000 |
| Manufacturer Country | US |
| Manufacturer Postal | 074700000 |
| Manufacturer G1 | MAQUET MEDICAL SYSTEMS USA |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07470 0000 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAQUET FEMUR HOOK WITH SUPPORT ARM |
| Generic Name | HOOK, BONE, PRODUCT CODE KIK |
| Product Code | KIK |
| Date Received | 2014-02-19 |
| Model Number | 1433.42A0 |
| Catalog Number | 1433.420A0 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET GMBH |
| Manufacturer Address | KEHLER STR. 31 RASTATT 76437 GM 76437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-19 |