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

Model Number	100042-06
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Bacterial Infection (1735); Seroma (2069)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per clinical trial (b)(4): on (b)(6) 2019, patient underwent bilateral augmentation mastopexy using a vertical incision.Two pieces of galashape (galaflex 3d) were used.On (b)(6) 2019, right breast seroma was reported.On (b)(6) 2019, patient had debridement of right breast wound as well as removal of exposed right breast implant and exposed galashape (galaflex 3d) mesh.Replacement of right breast implant and primary closure of right breast open wound.Patient was treated with medication (keflex 500mg, cipro 500mg).On (b)(6) 2019, right breast infection was reported,(serratia marcescens and pseudomonas aeruginosa.) patient was treated with continued medication (keflex 500mg, cipro 500mg).Resolved with sequelae on (b)(6) 2019.On (b)(6) 2019, patient had debridement of small opening of right breast incision.Resolved without sequelae on (b)(6) 2019.Review by medical affairs identifies the reported seroma and infection are likely related to the device and serious.
Additional Manufacturer Narrative
Based on the information available, no conclusions can be made.As reported the patient developed a seroma and infection post implant of galaflex 3d mesh and underwent subsequent surgical intervention for explant.Medical affairs has assessed the aes as being likely related to the device and serious.Review of the device history records confirms the device was manufactured to specification.Seroma and infection are known inherent risks of surgery/use of the device and are included as a possible complication in the adverse reaction section of the instructions-for-use (ifu), supplied with the device.Regarding 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." not returned - explanted.

• Brand Name: GALAFLEX 3D
• Common Device Name: 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: 15713414
• Report Number: 1213643-2022-00688
• Device Sequence Number: 6656431
• Product Code: OOD
• UDI-Device Identifier: 00855920006195
• UDI-Public: (01)00855920006195
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2022

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: 07/11/2021
• Device Model Number: 100042-06
• Device Catalogue Number: SH3D06
• Device Lot Number: 190304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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: 23 YR
• Patient Sex: Female
• Patient Weight: 71 KG