MAUDE Adverse Event Report: BIOTISSUE HOLDINGS INC. PROKERA; CONFORMER, OPHTHALMIC, BIOLOGICAL TISSUE

Model Number AE-32805

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Patient tried and failed - not assisting with symptoms.Pae reported by hcp, who does not consent to follow up.(b)(6).

• Brand Name: PROKERA
• Type of Device: CONFORMER, OPHTHALMIC, BIOLOGICAL TISSUE
• Manufacturer (Section D): BIOTISSUE HOLDINGS INC.
• MDR Report Key: 16876801
• MDR Text Key: 314729017
• Report Number: MW5117251
• Device Sequence Number: 1
• Product Code: NQB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AE-32805
• Patient Sequence Number: 1