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

Model Number	100035-15
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	07/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per clinical trial (b)(4): on (b)(6) 2016, patient underwent bilateral revision augmentation; capsular contracture, using an imf incision.2 pieces of galaflex (device #1 and device #2) were used.Concomitant procedure included bilateral capsulectomy.On (b)(6) 2016, bilateral breast seromas were reported.Reported as sae.Patient had aspiration of both seromas on (b)(6) 2016 and (b)(6) 2016.Patient was also treated with medication (keflex 500mg).Wearing post surgical bandeau bra.Resolved without sequelae on (b)(6) 2016.Review by medical affairs identifies the adverse event as likely related to the device and serious.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, patient experienced post-op complication of seroma, underwent aspiration and treated with medication.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.Seroma 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).This mdr is submitted to represent the galaflex (device #1).An additional mdr is submitted to represent the galaflex (device #2).Note: this mdr report is related to a retrospective study conducted to proactively gather real-world evidence on the use and safety of the p4hb 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 - 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: 14693613
• Report Number: 1213643-2022-00415
• Device Sequence Number: 5752501
• Product Code: OOD
• UDI-Device Identifier: 00855920006034
• UDI-Public: (01)00855920006034
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2022

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: 06/30/2017
• Device Model Number: 100035-15
• Device Catalogue Number: GP0408
• Device Lot Number: 140411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2014
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 50 KG