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

Model Number	100042-01
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, patient underwent breast augmentation revision surgery on (b)(6) 2022 with the implant of galaflex 3d scaffold.As reported 8 months post implant, patient had inferior margin right breast retracted.It was reported during exam, palpation revealed a firm ridge which is "assumed to be rolled galatea mesh." no medical or surgical intervention has been reported.Patient is scheduled to follow up with surgeon, will be advised of the absorption rate and further treatment will be planned.
Additional Manufacturer Narrative
As reported 8 months post implant, the patient presented with inferior margin right breast retracted.It was reported during exam, palpation revealed a firm ridge which is "assumed to be rolled galatea mesh".Based on the information provided, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in aug, 2019.Note, the date of event (b)(6) 2023) is provided as an estimate based on the information provided.Remains implanted.
Additional Manufacturer Narrative
As reported 8 months post implant, the patient presented with inferior margin right breast retracted.It was reported during exam, palpation revealed a firm ridge which is "assumed to be rolled galatea mesh".Based on the information provided, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in aug, 2019.Note, the date of event (15-feb-2023) is provided as an estimate based on the information provided.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to correct the medical device implant date.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.H3 other text : not returned - remains implanted.
Event or Problem Description
As reported, patient underwent breast augmentation revision surgery on (b)(6) 2022 with the implant of galaflex 3d scaffold.As reported 8 months post implant, patient had inferior margin right breast retracted.It was reported during exam, palpation revealed a firm ridge which is "assumed to be rolled galatea mesh." no medical or surgical intervention has been reported.Patient is scheduled to follow up with surgeon, will be advised of the absorption rate and further treatment will be planned.

• Brand Name: GALAFLEX 3D
• 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: 16577446
• Report Number: 1213643-2023-00107
• Device Sequence Number: 1634915
• Product Code: OOD
• UDI-Device Identifier: 00810054980261
• UDI-Public: (01)00810054980261
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: 03/30/2025
• Device Model Number: 100042-01
• Device Catalogue Number: SH3D01
• Device Lot Number: 210392
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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: 62 YR
• Patient Sex: Female