MAUDE Adverse Event Report: TISSUETECH, INC. PROKERA OPHTHALMIC BIOLOGICAL TISSUE ; COMFORMER, OPHTHALMIC BIOLOGIC TISSUE

Lot Number 19PKCLR00159

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2020

Event Type  malfunction  

Event Description

Blue rubber ring detached from prokera clear in pt's eye.Fda safety report id# (b)(4).

• Brand Name: PROKERA OPHTHALMIC BIOLOGICAL TISSUE
• Type of Device: COMFORMER, OPHTHALMIC BIOLOGIC TISSUE
• Manufacturer (Section D): TISSUETECH, INC.
• MDR Report Key: 9695001
• MDR Text Key: 178961354
• Report Number: MW5092924
• Device Sequence Number: 1
• Product Code: NQB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 19PKCLR00159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 YR