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

Model Number	100035-01
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Discomfort (2330); Ptosis (2620); Skin Inflammation/ Irritation (4545); Physical Asymmetry (4573)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, on (b)(6) 2025 during a breast augmentation procedure the patient was implanted with galaflex implant.Reportedly, one (1) mesh was divided into two (2) and implanted bilaterally in the patient.Post one (1) year of implantation the patient had discomfort, pulling sensations bilaterally from the bottom of her breasts, feeling like her implants are 'stuck' in her mesh that hasn't dissolved in a year's time, irritating sensation making patient want to "crawl out of her skin".It was also reported that, the affected side is bilaterally, more pronounced on the right.For the post-operative complications a revision surgery has been scheduled on (b)(6) 2026.As per the clinical findings, the patient has grade one (1) ptosis and the mesh is folded in the right breast.Patient has been advised to get a mammogram prior to her upcoming surgery.
Additional Manufacturer Narrative
As reported, post implantation of galaflex, the patient had discomfort, grade one (1) ptosis in the right beast, pulling sensations bilaterally from the bottom of her breasts, feeling like her implants are 'stuck' in her mesh that hasn't dissolved in a year's time and irritating sensation.For the post-operative complications a revision surgery has been scheduled.Based on the information provided the degree to which the galaflex implant used to treat the patient, may have caused or contributed to the patient's postoperative course is unknown.A review of manufacturing records was conducted and shows the product was manufactured to specification.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.
Event or Problem Description
As reported, on (b)(6)2025 during a breast augmentation procedure the patient was was implanted with galaflex implant.Reportedly, one (1) mesh was divided into two (2) and implanted bilaterally in the patient.Post one (1) year of implantation the patient had discomfort, pulling sensations bilaterally from the bottom of her breasts, feeling like her implants are 'stuck' in her mesh that hasn't dissolved in a years time, irritating sensation making patient want to "crawl out of her skin".It was also reported that, the affected side is bilaterally, more pronounced on the right.For the post-operative complications a revision surgery has been scheduled on (b)(6)2026.As per the clinical findings, the patient has grade one (1) ptosis and the mesh is folded in the right breast.Patient has been advised to get a mammogram prior to her upcoming surgery.
Additional Manufacturer Narrative
As reported, post implantation of galaflex, the patient had discomfort, grade one (1) ptosis in the right beast, pulling sensations bilaterally from the bottom of her breasts, feeling like her implants are 'stuck' in her mesh that hasn't dissolved in a year's time and irritating sensation.For the post-operative complications a revision surgery has been scheduled.Based on the information provided the degree to which the galaflex implant used to treat the patient, may have caused, or contributed to the patient's postoperative course is unknown.A review of manufacturing records was conducted and shows the product was manufactured to specification.Addendum: h11: this is an addendum to the initial mdr submitted to correct the product unique identifier (udi).Updated fields: b4, g3, g6, h2, h10, h11 corrected field: d4 (unique identifier (udi)#) 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
• Common Device Name: BREAST - 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: 24967617
• Report Number: 1213643-2026-00552
• Device Sequence Number: 10455950
• Product Code: OOD
• UDI-Device Identifier: 00855920006010
• UDI-Public: (01)00855920006010(17)261231(10)LXJP0047
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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 Model Number: 100035-01
• Device Catalogue Number: GP0206
• Device Lot Number: LXJP0047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2024
• 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: Other
• Patient Age: 50 YR
• Patient Sex: Female