MAUDE Adverse Event Report: TEPHA, INC. - 3005670760 GALAFLEX 3DR; ABSORBABLE MESH

Model Number	100043-04
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Ptosis (2620)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent implant exchange with galaflex 3dr bilateral to support an imf on (b)(6) 2024 and in less than 6 months patient had already bottomed out through the capsulorrhaphy and the galaflex 3dr bilateral.As reported, surgeon planned to have a revision surgery on (b)(6) 2024 to do more capsulorrhaphy (suture and thermal) as well as secure more galaflex into place so it doesn¿t rotate.
Additional Manufacturer Narrative
As reported, patient experienced bottoming out post implant of galaflex 3dr.Based on the information provided, no conclusions can be made as to what if any extent the mesh caused or contribute to the patients post operative course.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in feb 2022.Note, the date of event (22-aug-2024) is considered to be a best estimate based.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: GALAFLEX 3DR
• Common Device Name: ABSORBABLE MESH
• Manufacturer (Section D): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer (Section G): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 20200853
• Report Number: 1213643-2024-00449
• Device Sequence Number: 6674437
• Product Code: OOD
• UDI-Device Identifier: 00810054980032
• UDI-Public: (01)00810054980032(17)250923(10)220042
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2025
• Device Model Number: 100043-04
• Device Catalogue Number: FR3D04
• Device Lot Number: 220042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 73 KG