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 Codes	Pocket Erosion (2013); Unspecified Reproductive System or Breast Problem (4513)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of galaflex p4hb construct, patient was diagnosed with right breast mechanical collapse.Based on the information provided, no conclusions can be made.A caused for post-op complication was not identified.In an abundance of caution, events for which relatedness cannot be completely ruled out are processed for mdr reporting.Review of manufacturing records shows product was manufactured to specification.No problem detected.Not returned.
Event or Problem Description
As reported, on (b)(6) 2018 subject 481-38 was treated with p4hb construct to treat right breast cancer mastoplexy.Date of onset (b)(6) 2019 experienced, mechanical collapse of the p4hb construct, right breast.(b)(6) 2019 identifies continuation of tighter skin envelope due to radiation and scarring preventing sufficient projection from chest.On (b)(6) 2019 reoperation performed with the initial construct that collapsed being removed and replaced with a new construct used.

• 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: 15763441
• Report Number: 1213643-2022-00714
• Device Sequence Number: 20393057
• 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
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2022

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: 12/31/2020
• Device Model Number: 100035-09
• Device Catalogue Number: GP0608
• Device Lot Number: 180150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 73 KG