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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Discomfort (2330)

Event Date 07/05/2021

Event Type  Injury  

Event Description

Patient was treated with prokera slim on (b)(6) 2021.Patient indication was superficial keratitis.The patient had the prokera removed the day after insertion due to discomfort.Upon removal, the treating physician noted signs of a possible infection.The patient's eye was not cultured as a result.The patient was prescribed antibiotic ophthalmic drops.The infection had resolved by the time of their follow-up appointment with the treating physician.

• 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: 12335979
• MDR Text Key: 267212857
• Report Number: 3009809074-2021-00006
• 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: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2023
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: BTR198806
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2021
• 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