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

Model Number	100042-02
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Cyanosis (1798)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, the patient was diagnosed with cyanotic in left nipple and was treated with medication.Medical affairs has assessed the patient¿s cyanotic as being serious and likely related to the study device.Review of the device history records confirmed the device was manufactured to specification.This mdr report is related to a retrospective study conducted to proactively gather real-world evidence on the use and safety of the p4hb product family, including galaflex scaffold, galaflex 3d, and galaflex 3dr. all safety events from the study are adjudicated by the bd medical monitor for an independent assessment of severity and relatedness. in an abundance of caution, events for which relatedness cannot be ruled out are processed for mdr reporting.Not returned.
Event or Problem Description
Per clinical trial (b)(6): on (b)(6) 2019, patient underwent bilateral revision augmentation; other (removal of implants) using a full vertical and horizontal t incision.2 pieces of galashape (galaflex 3d) were used.Concomitant procedures included mastopexy/autoaugmentation.On (b)(6) 2019, cyanosis of left nipple was reported.Patient was treated with medication (nitro paste).Resolved without sequelae on (b)(6) 2019.Review by medical affairs identifies the cyanosis as 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: 14985000
• Report Number: 1213643-2022-00503
• Device Sequence Number: 1613727
• Product Code: OOD
• UDI-Device Identifier: 00855920006157
• UDI-Public: (01)00855920006157
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/06/2022

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: 02/23/2021
• Device Model Number: 100042-02
• Device Catalogue Number: SH3D02
• Device Lot Number: 190140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2019
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 50 KG