MAUDE Adverse Event Report: PORIFEROUS, LLC SU-POR SURGICAL IMPLANTS

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erosion (1750)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

Patient experienced implant exposure 10 months after implantation resulting in implant removal.Patient suffers from diabetes, hypertension, and end stage renal disease, operating surgeon did not report any signs of infection or device failures.Device was removed without further complications and surgeon noted scar tissue from the implant created a firm eyelid.

Event Description

Patient presented with an exposure of a lower eyelid spacer implant.Patient suffers from diabetes, hypertensions and end stage renal disease.The implant was removed on (b)(6) 2020.The patient is "going great" according to operating surgeon and "scar tissue from implant has created a firm eyelid".

• Brand Name: SU-POR SURGICAL IMPLANTS
• Type of Device: SU-POR SURGICAL IMPLANTS
• Manufacturer (Section D): PORIFEROUS, LLC; 535 pine road; suite 206; newnan GA 30263
• Manufacturer (Section G): PORIFEROUS, LLC; 535 pine road; suite 206; newnan GA 30263
• Manufacturer Contact: krista bradstreet ; 535 pine road; suite 206; newnan, GA 30263 ; 7706833855
• MDR Report Key: 10726681
• MDR Text Key: 212728745
• Report Number: 3010781616-2020-00062
• Device Sequence Number: 1
• Product Code: KKY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR