MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-18 for OSSURE LOEP KIT AG11040302C manufactured by Agnovos Healthcare Usa, Llc.
[175646121]
The ossure loep kit is not marketed in the united states, and it is only exported from the usa. The implant material in the ossure loep kit is equivalent to the implant material identified in 510(k) #k181342.
Patient Sequence No: 1, Text Type: N, H10
[175646122]
Patient underwent bilateral local osteo-enhancement procedure (loep). Shortly after finishing the procedure, patient became unstable (~16h40) and was transferred to intensive care at around 18h00. An echocardiogram showed heart in a really weak state, a condition previously unknown to family or treating physician. Patient was treated with levophed and reanimated multiple times. Patient deceased at around 22h15. Surgeon reported to agnovos that the death was not related to the ossure device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011662387-2020-00001 |
| MDR Report Key | 9604847 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-18 |
| Date of Report | 2020-01-18 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2019-12-19 |
| Device Manufacturer Date | 2017-12-31 |
| Date Added to Maude | 2020-01-18 |
| 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 | DR. RONALD HILL |
| Manufacturer Street | 7301 CALHOUN PLACE SUITE 100 |
| Manufacturer City | ROCKVILLE MD 20855 |
| Manufacturer Country | US |
| Manufacturer Postal | 20855 |
| Manufacturer Phone | 2407536417 |
| Manufacturer G1 | AGNOVOS HEALTHCARE USA, LLC |
| Manufacturer Street | 7301 CALHOUN PLACE SUITE 100 |
| Manufacturer City | ROCKVILLE MD 20855 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 20855 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSSURE LOEP KIT |
| Generic Name | AGN1 LOEP KIT |
| Product Code | MQV |
| Date Received | 2020-01-18 |
| Catalog Number | AG11040302C |
| Lot Number | 2018000085 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGNOVOS HEALTHCARE USA, LLC |
| Manufacturer Address | 7301 CALHOUN PL STE 100 ROCKVILLE MD 20855 US 20855 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-01-18 |