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

Model Number	100042-06
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	12/16/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per clinical trial cp-(b)(4): on (b)(6) 2016, patient underwent bilateral revision mastopexy with auto-augmentation using an 'other' incision : areola, wise pattern superior pedicle.2 pieces of galashape (galaflex 3d) were used.Concomitant procedures were liposuction, mastopexy, auto-augmentation.On (b)(6) 2016, bilateral breast seroma was reported.Sae.Patient had procedures of aspiration of seroma beginning (b)(6) 2016.Serosanguinous drainage evacuated from both breasts on several dates.Resolved without sequelae on (b)(6) 2017.Review by medical affairs identifies the reported seroma is likely related to the device and serious.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, patient experienced post-op complications of seroma.Medical affairs has assessed the patient¿s postoperative course as being serious and likely related to the study device.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Seroma is a known inherent risk of the surgery/use of the device and included as a possible complication in the adverse reaction section of the ifu.Not returned - remains implanted.

• 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: 14654250
• Report Number: 1213643-2022-00410
• Device Sequence Number: 17420558
• Product Code: OOD
• UDI-Device Identifier: 00810054980315
• UDI-Public: (01)00810054980315
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2022

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: 100042-06
• Device Catalogue Number: SH3D06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 74 KG