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

Model Number	100035-09
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information available, no conclusions can be made.As reported, patient experienced post-op complication of erythema/redness.Medical affairs has assessed the aes as being likely related to the device and serious.Review of the device history records confirms the device was manufactured to specification.Remains implanted.
Event or Problem Description
Per clinical trial (b)(4): on (b)(6) 2018, patient underwent bilateral mastopexy/reduction; medial pedicle, using a wise pattern - superiomedial pedicle.2 pieces of galaflex were used.Concomitant procedures included: fat grafting to breasts/ liposuction to flanks, upper back, buffalo hump, abdomen, axilla.On (b)(6) 2018, erythema/redness; right vertical incision, was reported.Patient treated with medication (cipro 500mg).Betadine and non-stick pad.Resolved without sequelae on (b)(6) 2018.Review of medical affairs identified that the erythema/redness is likely related to the device and serious.

• 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: 15711876
• Report Number: 1213643-2022-00682
• Device Sequence Number: 20490737
• Product Code: OOD
• UDI-Device Identifier: 00855920006041
• UDI-Public: (01)00855920006041
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2022

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: 03/31/2020
• Device Model Number: 100035-09
• Device Catalogue Number: GP0608
• Device Lot Number: 170308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2017
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 90 KG