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

Catalog Number	GFLT1020
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, one month post implant of galaflex lite, the patient breasts were asymmetrical.Based on the information provided, no conclusion can be made.Review of manufacturing records shows product was manufactured to specification.Note, the date of event is estimated as (b)(6) 2022 based on the available information.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) 2022, the patient underwent bilateral breast augmentation with implant removal/replacement and a mastopexy during which a segment of galaflex lite was implanted at the lower pole and approximated with sutures.It was reported that about one-month post-implant, the patient's breasts were asymmetrical and ¿do not look good.¿.

• Brand Name: GALAFLEX LITE
• 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: 15326409
• Report Number: 1213643-2022-00606
• Device Sequence Number: 5375252
• Product Code: OOD
• UDI-Device Identifier: 00810054980575
• UDI-Public: (01)00810054980575
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2022

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 Expiration Date: 03/31/2023
• Device Catalogue Number: GFLT1020
• Device Lot Number: 210312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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 Sex: Female