MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-14 for L-PRF manufactured by Intralcok International.
[18629323]
Diagnosis or reason for use: l-prf used for bone graft improved handling. Exaggerated post-operative swollen. Found out the fda application for the intra-spin 210k approval for this device, was submitted with false information to the fda. The application was completed using a predicate device that uses sterile disposables to process the blood, but the intra-spin system uses tubes that are not sterile, putting the patients health and life at risk, because the device is used for invasive bone surgery procedures. I am available to explain more to the fda. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040858 |
| MDR Report Key | 4541054 |
| Date Received | 2015-02-14 |
| Date of Report | 2015-02-14 |
| Date of Event | 2014-02-07 |
| Date Added to Maude | 2015-02-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | L-PRF |
| Generic Name | INTRA-SPIN SYSTEM |
| Product Code | ORG |
| Date Received | 2015-02-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTRALCOK INTERNATIONAL |
| Manufacturer Address | BOCA RATON FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-14 |