MAUDE Adverse Event Report: TEPHA, INC. GALAFLEX 3D; GALAFLEX 3D (ALSO KNOWN AS GALASHAPE 3D)

Model Number	100042-05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urticaria (2278)
Date of Event	12/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient provided information in her communication to the manufacturer.No patient details (age, weight etc.) provided.Device history records were reviewed and product met all specifications.Sterilization process was completed per validated parameters.The manufacturer has made several attempts to obtain additional information and details from the patients' physician but have been unsuccessful.
Event or Problem Description
Patient reported that on (b)(6) 2020 she underwent corrective reconstruction with implant exchange.Her implants were changed to the same allergan natrelle implants.Her physician also used galashape 3d scaffold (now known as galaflex 3d).On (b)(6) 2020 she finished her antibiotics (which was an antibiotic she had previously taken).She did not make any changes to soaps or detergents and reviewed that with her physicians.On (b)(6) 2020 she began having systematic itchy hives.It began with her hands and the inside of her ears and throat.No swelling.Since then, she continues to have hives every day, off and on.The hives appear everyday on her underarms and arms.The hives have also appeared on her breasts, back, stomach, feet, ankles off and on.The only area that has not shown any hives or itching is her face.She has visited with her primary care physician, a dermatologist and an allergist.Currently she is being treated for urticaria.At the time of her report she was taking prednisone and a regimen of various allergy medications.

• Brand Name: GALAFLEX 3D
• Common Device Name: GALAFLEX 3D (ALSO KNOWN AS GALASHAPE 3D)
• Manufacturer (Section D): TEPHA, INC.; 99 hayden ave; suite 360; lexington MA 02421
• MDR Report Key: 11269581
• Report Number: 3005670760-2021-00001
• Device Sequence Number: 14479924
• Product Code: OOD
• UDI-Device Identifier: 00855920006188
• UDI-Public: 01008559200061881722032810200187
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2021

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: 03/28/2022
• Device Model Number: 100042-05
• Device Catalogue Number: SH3D05
• Device Lot Number: 200187
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR