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

Model Number	100043-04
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	08/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, patient experienced postoperative left breast infection and underwent mesh explant.Medical affairs has assessed the patient¿s postoperative course as being serious and likely related to the study device.Review of the device history records confirmed the device was manufactured to specification.Infection is a known inherent risk of the surgery/use of the device and listed as a possible complication in the adverse reaction section of the instruction for use (ifu) supplied with the device.In regards to 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." note: this mdr report is related to a (b)(6) study conducted to proactively gather real-world evidence on the use and safety of the (b)(4) 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.Not returned - mesh explanted.
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.Two pieces of galaform (galaflex 3dr) were used.Concomitant procedures included abdominoplasty, lipo suction, fat grafting to buttocks.On (b)(6) 2019, left breast infection ( (b)(6)) was reported.On (b)(6) 2019, patient had additional surgery as treatment - left breast exploration and debridement with removal of breast implant and mesh per prior notes, with placement of blake drain.Patient also treated with medications from (b)(6) 2019, at different timepoints.(iv beta lactam, iv ceftriaxone sodium.Also, cipro, bactrim, probiotics, gabapentin, percocet, toradol).Resolved on unknown date after (b)(6) 2019.Review by medical affairs identifies the reported ae as likely 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: 14159238
• Report Number: 1213643-2022-00167
• Device Sequence Number: 11499421
• Product Code: OOD
• UDI-Device Identifier: 00855920006256
• UDI-Public: (01)00855920006256
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2022

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: 08/12/2020
• Device Model Number: 100043-04
• Device Catalogue Number: FR3D04
• Device Lot Number: 180352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2018
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 68 KG