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	Breast Cancer (1759)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient was diagnosed post implant with breast cancer recurrence.The surgeon did not identify any causal relationship between the cancer patient experiencing a recurrence and the use of 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.Not returned.
Event or Problem Description
As reported, patient was implanted with galaflex on (b)(6) 2018.On (b)(6) 2021 patient was diagnosed with right breast cancer recurrence.Annual mammogram showed a new mass in same location as initial cancer occurrence.Dx: invasive ductal carcinoma (same dx as initial occurrence).On (b)(6) 2021 biopsy addendum noted hypoechoic nodule is at the interface between the superficial tissues and the shadowing along the fat grafting postsurgical change.As reported, the treating surgeon identified the condition of the recurring cancer as not caused by the use of the galaflex (p4hb) implant used to treat the patient.
Additional Manufacturer Narrative
As reported, the patient was diagnosed post implant with breast cancer recurrence.The surgeon did not identify any causal relationship between the cancer patient experiencing a recurrence and the use of 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.Addendum: h11: this supplemental mdr is submitted to correct medical device manufacturer and udi.Note: section a through f - 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.
Event or Problem Description
As reported, patient was implanted with galaflex on (b)(6) 2018.On (b)(6) 2021 patient was diagnosed with right breast cancer recurrence.Annual mammogram showed a new mass in same location as initial cancer occurrence.Dx: invasive ductal carcinoma (same dx as initial occurrence).On 17-sep-2021 biopsy addendum noted hypoechoic nodule is at the interface between the superficial tissues and the shadowing along the fat grafting postsurgical change.As reported, the treating surgeon identified the condition of the recurring cancer as not caused by the use of the galaflex (p4hb) implant used to treat the patient.

• 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: 15326325
• Report Number: 1213643-2022-00597
• Device Sequence Number: 6293903
• Product Code: OOD
• UDI-Device Identifier: 00855920006041
• UDI-Public: (01)00855920006041(17)200331(10)170308
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 62 YR
• Patient Sex: Female