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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISSUETECH, INC. PROKERA; PROKERA SLIM
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TISSUETECH, INC. PROKERA; PROKERA SLIM Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Corneal Infiltrates (2231)
Event Type  Injury  
Event Description
A physician posted an inquiry on docmatter, an online collaboration platform for health professionals, indicating they had a patient case that presented with 2 small corneal infiltrates after prokera treatment.The physician stated they removed the prokera and treated the patient with topical antibiotics.The patient recovered well.The post was an inquiry as to whether other physician's have had a similar experience with prokera.Tissuetech, inc.'s medical director made repeat attempts to contact the treating physician to gather additional information regarding this case but a response has not been received.Device identifying information was also requested from the physician and has not been received.No additional information was provided regarding this event.
 
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Brand Name
PROKERA
Type of Device
PROKERA SLIM
Manufacturer (Section D)
TISSUETECH, INC.
8305 nw 27th st
ste 101
doral FL 33122
MDR Report Key12548001
MDR Text Key273819365
Report Number3009809074-2021-00010
Device Sequence Number1
Product Code NQB
Combination Product (y/n)N
PMA/PMN Number
K032104
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberNOT PROVIDED
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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