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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES MITEK SPORTS MEDIC PEAR PLATELET RICH PLASMA SYSTEM
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DEPUY SYNTHES MITEK SPORTS MEDIC PEAR PLATELET RICH PLASMA SYSTEM Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 09/15/2015
Event Type  malfunction  
Event Description
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.
 
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Brand Name
PEAR PLATELET RICH PLASMA SYSTEM
Type of Device
PEAR PLATELET RICH PLASMA SYSTEM
Manufacturer (Section D)
DEPUY SYNTHES MITEK SPORTS MEDIC
MDR Report Key5204282
MDR Text Key30643395
Report NumberMW5057693
Device Sequence Number1
Product Code KSS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age59 YR
Patient Weight86
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