MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-02-19 for MAQUET FEMUR HOOK WITH SUPPORT ARM manufactured by Maquet Gmbh.
[21877357]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[22004492]
A maquet field service technician inspected the accessory and found it had been damaged. The device was removed from service and a new unit provided to the customer. The damage device is being returned for evaluation. Additional information will be provided in a follow-up report. Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010652-2014-00002 |
| MDR Report Key | 3716277 |
| Report Source | 05,06,07 |
| Date Received | 2014-02-19 |
| Date Mfgr Received | 2014-01-20 |
| Date Added to Maude | 2014-04-04 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. JANICE PEVIDE |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097753 |
| Manufacturer G1 | MAQUET GMBH |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76437 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| 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 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET GMBH |
| Manufacturer Address | KEHLER STRASSE 31 RASTATT 76437 GM 76437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-19 |