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

Model Number	100035-23
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	12/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Per clinical trial cp-1060: on (b)(6) 2017, patient underwent bilateral superior breast reduction using a full vertical and horizontal t incision.2 pieces of galaflex (device #1 and device #2) were used.Concomitant procedures included liposuction of lateral breasts and chin.On (b)(6) 2017, delayed wound healing of bilateral breasts at t junction of incisions was reported.Patient did not receive any treatment/medication.Resolved without sequelae on (b)(6) 2018.Review by medical affairs identifies the reported ae is likely related to the device and not serious.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, patient experienced the post-op complication of delayed wound healing.Medical affairs has assessed the patient¿s postoperative course as not-serious and likely related to the study device.Review of the device history records confirmed the device was manufactured to specification.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.Device 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: 14636562
• Report Number: 1213643-2022-00396
• Device Sequence Number: 17663702
• Product Code: OOD
• UDI-Device Identifier: 00855920006058
• UDI-Public: (01)00855920006058
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 100035-23
• Device Catalogue Number: GP016S
• Device Lot Number: 160443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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: Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 68 KG