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

Lot Number BTR183554

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cyst(s) (1800); Excessive Tear Production (2235)

Event Date 03/11/2021

Event Type  Injury  

Event Description

Tti received report of an patient adverse event from sales rep, (b)(6).The initial communication stated that the patient was treated with prokera slim for recurrent corneal erosion.Tti medical director was notified of this event on (b)(6) 2021.The treating physician performed a debridement and placed a pks on the eye, and prescribed the patient ofloxicin.The patient experienced continuous eye tearing and the formation of cysts on the eye.The patient was then referred to a cornea specialist who scraped the eye and placed a bandage contact lens.The initial communication stated that the patient is well and the patient symptoms resolved after placement of the bandage contact lens.The treating physician was contacted to provide additional information but a response has not yet been received.No product defect was reported by the customer.The form indicated the device was discarded by the customer.The manufacturing batch record for associated lot was reviewed and no nonconformities identified.Review of complaint records indicate no other complaints have been received for the associated lot.

• 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: 11724001
• MDR Text Key: 247277032
• Report Number: 3009809074-2021-00003
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2022
• Device Lot Number: BTR183554
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2021
• Date Device Manufactured: 01/24/2020
• 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): Other; Required Intervention