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

Model Number	100035-15
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per clinical trial (b)(4): on (b)(6) 2016, patient underwent bilateral breast reduction; superior pedicle, using a full vertical and horizontal t incision.Two pieces of galaflex were used and cut in an elliptical shape.Concomitant procedure was liposuction of axilla.On (b)(6) 2016, left breast infection (mrsa) was reported.Patient was treated with iv antibiotic (daptomycin, for approx.3 weeks) and other medications (keflex, doxycycline, vicopaste).Review of medical affairs identified that the infection is likely related to the device and serious.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, patient was diagnosed with post-op complication of left breast infection.Medical affairs has assessed the patient¿s postoperative course as being serious and likely related to the study device.Review of the device history records confirmed the device was manufactured to specification.Infection is a known inherent risk of the surgery/use and listed as a possible complication in the adverse reaction section of the instruction for use (ifu) supplied with the device.In regards to infection the warnings section of the ifu states, "if an infection develops, treat the infection aggressively.An unresolved infection may require removal of the scaffold." not returned - remains implanted.

• Brand Name: GALAFLEX
• 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: 15713374
• Report Number: 1213643-2022-00686
• Device Sequence Number: 6675574
• Product Code: OOD
• UDI-Device Identifier: 00855920006034
• UDI-Public: (01)00855920006034
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2022

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: 01/31/2018
• Device Model Number: 100035-15
• Device Catalogue Number: GP0408
• Device Lot Number: 150155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2015
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 79 KG