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

Model Number	100042-04
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	04/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, patient diagnosed with post-op complication of hematoma.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.Hematoma is a known inherent risk of the surgery/use of the device and included as a possible complication in the adverse reaction section of the instructions for use (ifu) supplied with the device.This mdr reports the ae of hematoma.An additional mdr was submitted to report additional ae of explanted tepha mesh related to non-tepha implant rupture.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 - explanted.
Event or Problem Description
Per clinical trial (b)(4): on (b)(6) 2017, patient underwent bilateral augmentation mastopexy using a vertical incision.2 pieces of galashape (galaflex 3d) were used.Concomitant procedures included neck lift, fx laser cheeks and upper lip.On (b)(6) 2017, hematoma left breast was reported.Sae.On (b)(6) 2017, patient had drainage of hematoma and was treated with medication (keflex).End date was (b)(6) 2017 without noted outcome.Review by medical affairs identifies the reported hematoma is likely related to the device and serious.On (b)(6) 2017, a ruptured left breast implant (non-tepha) was reported.Sae.On (b)(6) 2017, patient had left breast implant (non-tepha) and left tepha mesh removed.Patient also received medication (keflex, cipro).Resolved with sequelae on (b)(6) 2017.Review by medical affairs identifies the reported ruptured implant is likely related to the device and serious.On (b)(6) 2019 patient did have another bilateral revision augmentation, and 2 pieces of galaflex were used.No aes during the procedure or documented afterwards.

• Brand Name: GALAFLEX 3D
• 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: 14478515
• Report Number: 1213643-2022-00291
• Device Sequence Number: 14622859
• Product Code: OOD
• UDI-Device Identifier: 00855920006171
• UDI-Public: (01)00855920006171
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

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: 08/27/2017
• Device Model Number: 100042-04
• Device Catalogue Number: SH3D04
• Device Lot Number: 170060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 59 KG