MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-02 for PEAR PLATELET RICH PLASMA SYSTEM manufactured by Depuy Synthes Mitek Sports Medic.
[30643395]
I received a prp injection in both knees at (b)(6). They used the peak platelet rich plasma system (510k clearance on march 25, 2014: bk130053) to produce a 3cc aliquot of prp from 27cc of my blood (plus 3cc of anticoagulant) - she did this twice, one for each knee. The tech performed the automated separation in front of me and she appeared to follow the manufacturer's instructions for this automated device. The resultant 3cc injections were red in color, not yellow; and i subsequently did not notice any benefit from these injections. I don't know how the 510k application could claim this device produces plasma (platelet-enriched or otherwise) when the resultant liquid is red instead of yellow. According to the physician, he spoke to the rep before my next injection, but the rep could offer no insight. Consequently, my last prp injections were done using other technology - which resulted in liquid that actually looked like plasma, and the injections seemed to have the desired effect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057693 |
| MDR Report Key | 5204282 |
| Date Received | 2015-11-02 |
| Date of Report | 2015-11-02 |
| Date of Event | 2015-09-15 |
| Date Added to Maude | 2015-11-05 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PEAR PLATELET RICH PLASMA SYSTEM |
| Generic Name | PEAR PLATELET RICH PLASMA SYSTEM |
| Product Code | KSS |
| Date Received | 2015-11-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES MITEK SPORTS MEDIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-02 |