MAUDE Adverse Event Report: TISSUETECH, INC. PROKERA; PROKERA SLIM

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Red Eye(s) (2038); Discomfort (2330)

Event Date 08/13/2021

Event Type  Injury  

Event Description

Patient was treated with prokera slim on (b)(6) 2021.Three days after insertion the patient presented with an infection.The patient experienced redness, swelling, and pain.The device was removed and the patient was successfully treated with oral and topical antibiotics.The treating physician indicated the only abnormality observed with the device is that the storage solution appeared milky white compared to other prokeras.The physician did not culture the solution or the patient's eye and the unit was not returned to tti for inspection.The manufacturing batch record for the pks lot was reviewed and no nonconformities identified.Final product microbiology testing for the prokera lot indicated no growth.At the time of report, all other units from the lot had been distributed and no other complaints received.Several units from a different prokera lot remained in-house that were manufactured the same day, with the same lot number of storage solution.Those 12 units that remained in inventory were confirmed to have clear stoarage solution.Em data collected in the clean room before and after the manufacture of the prokera lot were found to be within acceptable limits.

• Brand Name: PROKERA
• Type of Device: PROKERA SLIM
• Manufacturer (Section D): TISSUETECH, INC.; 8305 nw 27 st.; ste 101; doral FL 33122
• MDR Report Key: 12475959
• MDR Text Key: 271522424
• Report Number: 3009809074-2021-00009
• Device Sequence Number: 1
• Product Code: NQB
• Combination Product (y/n): N
• PMA/PMN Number: K032104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2023
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: BTR211645
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention