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 Codes	Erythema (1840); Itching Sensation (1943); Swelling/ Edema (4577)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, the patient experienced itching, swelling, and redness about 1 month post-implant of the galaflex 3d mesh, which improved after taking medications.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 586 units released for distribution in (b)(6) 2021.Not returned; remains implanted.
Event or Problem Description
As reported, the patient underwent breast reduction surgery with suspension and scaffold, liposuction to the suprapubic area on (b)(6) 2022.As reported, galaflex 3d mesh was implanted in bilateral breasts with no suture anchoring.As reported, patient started to experience itching, swelling and redness between the nipple areola complex's down to the inframammary fold incisions and laterally; on (b)(6) 2022, patient was prescribed keflex antibiotics for 2 weeks, instructed to take benadryl the next day ((b)(6) 2022), visit the er.As reported, it was noted that the patient's left breast redness and itching had reduced.As reported, the patient was instructed apply bacitracin twice daily to the areola followed by xeroform and was asked to take doxycycline if needed, after completion of the keflex course.As reported, the patient's symptoms appeared to be improving and was sent home the same evening.

• 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: 14186894
• Report Number: 1213643-2022-00184
• Device Sequence Number: 5755954
• Product Code: OOD
• UDI-Device Identifier: 00810054980292
• UDI-Public: (01)00810054980292
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

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: 12/19/2024
• Device Model Number: 100042-04
• Device Catalogue Number: SH3D04
• Device Lot Number: 210196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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: 25 YR
• Patient Sex: Female