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

Model Number	100035-09
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Purulent Discharge (1812)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, patient was implanted with a galaflex mesh on (b)(6) 2017.On (b)(6) 2018 patient was diagnosed with left breast implant failure to integrate and dimensional collapse.On (b)(6) 2018 30 cc yellow thick fluid was aspirated in the office.On (b)(6) 2018 10 cc yellow lipid fluid was aspirated.As reported the galaflex scaffold was collapsed and not attached to skin flap anteriorly that incision and drainage performed.As reported, the treating surgeon identified the condition of the left breast device failure to integrate and dimensional collapse as not caused by the use of the galaflex (p4hb) implant used to treat the patient.
Additional Manufacturer Narrative
As reported, post implant of galaflex, the patient experienced fluid discharge and left breast device failure to integrate.The surgeon did not identify any causal relationship between the failure to incorporate being due to the galaflex implant used to treat the patient.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.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Not returned - remains implanted.

• Brand Name: GALAFLEX
• 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: 15326342
• Report Number: 1213643-2022-00603
• Device Sequence Number: 6314611
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2022

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: 10/15/2021
• Initial Report FDA Received Date: 08/31/2022
• 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: 66 YR
• Patient Sex: Female