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

Lot Number BTR197514

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Event Description

Product issue form submitted for (b)(4) indicated a patient was treated with prokera and experienced a stinging sensation and spk.

• 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: 12099339
• MDR Text Key: 259590399
• Report Number: 3009809074-2021-00005
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2023
• Device Lot Number: BTR197514
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention