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 Codes	Bacterial Infection (1735); Fluid Discharge (2686)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, on (b)(6) 2020 patient was implanted with two galaflex devices (device#1, device #2) (gel foam used with lotus).On (b)(6) 2020 patient was diagnosed with right breast infection (ae1).Erythema noted initially and prescribed keflex by general surgeon without improvement.On (b)(6) 2020 incision, 50-70cc thick fluid drained, drain placed, and positive culture/sensitivity, continued antibiotics.Infection resolved (b)(6) 2020.On (b)(6) 2021 patient was diagnosed with right breast small weeping sinus (ae2).No fluid collection performed, however three punctuate "pinhole" openings in skin between nipple and site of cancer.On (b)(6) 2021 explant performed of right lotus with specimen negative for pathology.As reported, the treating surgeon identified the conditions of the infection and small weeping sinus as not caused by the use of the p4hb implants used to treat the patient.
Additional Manufacturer Narrative
As reported, post implant of galaflex mesh, the patient was diagnosed with right breast infection, small weeping sinus with mesh explant.The surgeon did not identify any causal relationship between the post-op complication 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.Infection is a known inherent risk of surgery/use of the device and is included as a possible complication in the adverse reaction section of the instructions-for-use (ifu).In regards to the infection, the warnings section of the ifu states: "if an infection develops, treat the infection aggressively.An unresolved infection may require removal of the scaffold." this mdr represent the galaflex (device #2) of lot #200278.An additional mdr has been submitted to represent the galaflex (device #1) of lot#190528.Not returned - explanted.

• 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: 15326333
• Report Number: 1213643-2022-00598
• Device Sequence Number: 6314604
• 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: 2020
• Device Explanted Year: 2021
• 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: 03/31/2022
• Device Model Number: 100035-09
• Device Catalogue Number: GP0608
• Device Lot Number: 200278
• 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: 08/05/2020
• 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: 41 YR
• Patient Sex: Female