MAUDE Adverse Event Report: TISSUE TECH, INC. PROKERA

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Foreign Body Sensation in Eye (1869); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Based off of the information provided, this event does not meet the criteria for a reportable event.This report is being submitted as an acknowledgement of receipt of the report from allergan as well as to document the attempt to contact the customer for additional information.Should the customer contact tissue tech, inc.In the future, a follow-up report will be submitted.

Event Description

Customer contacted restasis eye drops manufacturer, allergan, to report various issues including back pain, neck pain, and gritty feeling in the eyes.This was reported via mfr report #(b)(4).Allergan personnel contacted the patient and inquired about previous treatments/medications.Among other treatments and surguries, the customer stated they were previously treated with prokera, but that it had to be removed as it caused them pain and had folded in their eye.No further information was provided.The tti medical director was notified of the event and contacted the customer using the phone number provided by allergan.The customer did not answer the phone call but a voicemail was provided with the medical director's contact information on (b)(6) 2021.As of 02/04/2021, a response has not been received.Should the customer contact the md in the future, a follow-up report will be submitted.

• Brand Name: PROKERA
• Type of Device: PROKERA
• Manufacturer (Section D): TISSUE TECH, INC.; 8305 nw 27th st; ste 101; miami FL 33122
• MDR Report Key: 11317965
• MDR Text Key: 231583311
• Report Number: 3009809074-2021-00001
• 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: consumer
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LOTEMAX (LOTEPREDNOL ETABONATE)
• Patient Outcome(s): Other
• Patient Age: 66 YR