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

Model Number	100043-06
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Material Deformation (2976)
Health Effect - Clinical Code	Ptosis (2620)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, patient underwent a breast lift with no implant procedure in 2021.About a year later in 2022, patient underwent another breast lift with breast implants that were 400 cc.The following year on (b)(6) 2023 patient underwent a third revision procedure with an implant exchange to 310 cc implants and a breast lift implanting the galaflex 3dr.Shortly after the implant of galaflex 3dr, patient started to experience breasts bilaterally moving to the side with very little to no support.Patient reports going to surgeon numerous times with direction to wear a compression bra and taping her breasts to hold them in place.As the surgeon reported patient's breast did not hold, it is more noticeable with the right breast than the left and the galaflex 3dr did not work and will need a revision procedure.It was further reported that the patient underwent revision surgery on (b)(6) 2023.
Additional Manufacturer Narrative
As reported, during a breast lift procedure the galaflex 3dr was implanted, post implant patient's breast did not hold and underwent revision procedure.Based on the information provided, no conclusions can be made.Additional information has been requested regarding revision procedure, if/when additional information is received supplemental mdr will be submitted.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.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.
Event or Problem Description
As reported, patient underwent a breast lift with no implant procedure in 2021.About a year later in 2022, patient underwent another breast lift with breast implants that were 400 cc.The following year on (b)(6) 2023 patient underwent a third revision procedure with an implant exchange to 310 cc implants and a breast lift implanting the galaflex 3dr.Shortly after the implant of galaflex 3dr, patient started to experience breasts bilaterally moving to the side with very little to no support.Patient reports going to surgeon numerous times with direction to wear a compression bra and taping her breasts to hold them in place.As the surgeon reported patient's breast did not hold, it is more noticeable with the right breast than the left and the galaflex 3dr did not work and will need a revision procedure.It was further reported that the patient underwent revision surgery on (b)(6) 2023.Addendum per additional information: it was reported that the patient underwent repair for mesh removal on (b)(6) 2023.It was reported that the right implant removed the galaflex was noted to be secured to the inframammary fold but half the height and appeared to be folded over not providing support to the implant.It was reported that the galaflex was then removed from the inframammary fold tissue.It was also reported that the soft tissue where the implant had displaced was then closed with sutures to eliminate the dead space and another galaflex mesh was placed bilaterally to secure the capsular closure.
Additional Manufacturer Narrative
As reported, during a breast lift procedure the galaflex 3dr was implanted, post implant patient's breast did not hold and underwent revision procedure.Based on the information provided, no conclusions can be made.Additional information has been requested regarding revision procedure, if/when additional information is received supplemental mdr will be submitted.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.Addendum: this supplemental mdr is submitted to document the additional information received.Additionally, it was reported that the mesh was folded and explanted on (b)(6) 2023.Based on the information provided, no conclusions can be made.Updated fields: d6.B (date of explant).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.

• 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: 18053377
• Report Number: 1213643-2023-00399
• Device Sequence Number: 6074582
• Product Code: OOD
• UDI-Device Identifier: 00810054980056
• UDI-Public: (01)00810054980056
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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: 05/26/2026
• Device Model Number: 100043-06
• Device Catalogue Number: FR3D06
• Device Lot Number: LXGY0001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• 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: 59 YR
• Patient Sex: Female