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

Model Number	100027-10
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	12/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient underwent bilateral implant exchange and mastopexy procedure with the implant of two galaflex lite meshes in left and right breasts on (b)(6) 2023.It was reported that the patient was diagnosed with staphylococcus infection in the left breast and underwent revision surgery by removing the galaflex lite meshes from both breasts on (b)(6) 2023.The surgeon does not know what could have caused the patient's infection.It was reported that patient was treated with iv antibiotics and the infection was cleared.
Additional Manufacturer Narrative
As reported, patient developed bacterial infection in the left breast about fifteen days post implant of galaflex lite thereby underwent repair with mesh explant.Based on the information provided, no conclusions can be made as to the degree to which the device may have caused or contributed to the patient¿s clinical course.The instructions-for-use supplied with the device lists infection as a possible complication.In regard to infection, the warnings section in ifu states, "if an infection develops, treat the infection aggressively.An unresolved infection may require removal of the scaffold." review of manufacturing records confirms product was manufactured to specification.This mdr represents galaflex lite (device #1) implanted on left breast.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.
Additional Manufacturer Narrative
As reported, patient developed bacterial infection in the left breast about fifteen days post implant of galaflex lite thereby underwent repair with mesh explant.Based on the information provided, no conclusions can be made as to the degree to which the device may have caused or contributed to the patient¿s clinical course.The instructions-for-use supplied with the device lists infection as a possible complication.In regard to infection, the warnings section in ifu states, "if an infection develops, treat the infection aggressively.An unresolved infection may require removal of the scaffold." review of manufacturing records confirms product was manufactured to specification.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to correct the medical device expiration date.This supplemental mdr represents galaflex lite (device #1) implanted on left breast.An additional supplemental mdr was submitted to represents galaflex lite (device #2).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, the patient underwent bilateral implant exchange and mastopexy procedure with the implant of two galaflex lite meshes in left and right breasts on (b)(6) 2023.It was reported that the patient was diagnosed with staphylococcus infection in the left breast and underwent revision surgery by removing the galaflex lite meshes from both breasts on (b)(6) 2023.The surgeon does not know what could have caused the patient's infection.It was reported that patient was treated with iv antibiotics and the infection was cleared.

• Brand Name: GALAFLEX LITE
• 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: 19024496
• Report Number: 1213643-2024-00117
• Device Sequence Number: 17113859
• Product Code: OOD
• UDI-Device Identifier: 00810054980827
• UDI-Public: (01)00810054980827
• 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: 2023
• Device Explanted Year: 2023
• 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): 04/17/2024

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: 06/30/2025
• Device Model Number: 100027-10
• Device Catalogue Number: GFLT2530
• Device Lot Number: LXHU0015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2023
• 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