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

Model Number	100043-02
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported the galaflex 3dr mesh did not dissolve and the mesh was excised.Medical affairs has assessed the ae as being related to the device and serious.Review of the device history records confirms the device was manufactured to specification.Based on the information provided root cause as to why the mesh allegedly did not dissolve over time cannot be determined.As reported at the time of explant the mesh had been implanted for approximately 15-months.Per the instructions-for-use, supplied with the device, ¿bio-resorption of the scaffold material will be essentially complete within 18-24 months.The outer rim may be palpable throughout the expected period of healing.¿ note: 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.
Event or Problem Description
Per clinical trial (b)(4): on (b)(6) 2019, patient underwent bilateral augmentation mastopexy using a full vertical and horizontal t incision.2 pieces of galaform (galaflex 3dr) were used.No concomitant procedures were done.On (b)(6) 2020, an ae of: galaform did not dissolve; left lateral breast, was reported.Galaform was excised on 6/18/20.Resolved without sequelae on (b)(6) 2020.Review by medical affairs identifies the reported ae is related to the device and serious.

• Brand Name: GALAFLEX 3DR
• 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: 15123639
• Report Number: 1213643-2022-00544
• Device Sequence Number: 7372431
• Product Code: OOD
• UDI-Device Identifier: 00855920006232
• UDI-Public: (01)00855920006232
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• 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 Expiration Date: 06/24/2019
• Device Model Number: 100043-02
• Device Catalogue Number: FR3D02
• Device Lot Number: 180285
• 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
• Date Device Manufactured: 07/20/2018
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 61 KG