MAUDE Adverse Event Report: TEPHA, INC. - 3005670760 GALAFLEX 3D; BREAST - ABSORBABLE MESH

Model Number	100042-06
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, patient experienced post-op complications of erythema/redness.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.This mdr reports the ae of erythema/redness.Additional mdrs were submitted to report additional aes of wound dehiscence and edema.Not returned.
Event or Problem Description
Per clinical trial (b)(4): on (b)(6) 2019, patient underwent bilateral mastopexy/reduction; inferior pedicle, using a full vertical and horizontal t incision.2 pieces of galashape (galaflex 3d) were used.No concomitant procedures were done.On (b)(6) 2019, erythema/redness; bilateral breasts was reported.Patient was treated with medication (topical aquaphor).Resolved without sequelae on (b)(6) 2020.Review by medical affairs identifies the erythema/redness is likely related to the device and serious.

• Brand Name: GALAFLEX 3D
• 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: 15123711
• Report Number: 1213643-2022-00545
• Device Sequence Number: 12607983
• Product Code: OOD
• UDI-Device Identifier: 00855920006195
• UDI-Public: (01)00855920006195
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2022

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: 07/20/2022
• Initial Report FDA Received Date: 07/28/2022
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 68 KG