MAUDE Adverse Event Report: TEPHA, INC GALASHAPE 3D; SURGICAL SCAFFOLD

Model Number	100042-06
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on known information, there is no conclusive evidence that the device caused or contributed to the infection.Infection is a known inherent risk of surgery.Regarding infection- the warning section of the instructions for use states, "if an infection develops, treat the infection aggressively.An unresolved infection may require removal of the scaffold.".
Event or Problem Description
Physician reported that 9 days after the surgery; re-augmentation of left breast with implant and mesh located at the inferior pole (left breast only), the patient presented an elevated white blood cell count and showed signs and symptoms of an infection - redness, fever, malaise and aches.The patient was sent to the hospital, the breast implant and mesh were removed, the area flushed and a new implant was placed.No mesh was used in the second surgery.

• Brand Name: GALASHAPE 3D
• Common Device Name: SURGICAL SCAFFOLD
• Manufacturer (Section D): TEPHA, INC; 99 hayden ave; suite 360; lexington MA 02421
• MDR Report Key: 8000102
• Report Number: 3005670760-2018-00003
• Device Sequence Number: 16431810
• Product Code: OXF
• UDI-Device Identifier: 00855920006195
• UDI-Public: 01008559200061951718092410170413
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2018

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: 09/24/2018
• Device Model Number: 100042-06
• Device Catalogue Number: SH3D06
• Device Lot Number: 170413
• Was Device Available for Evaluation?: No
• Device Age: 10 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 10/24/2018
• 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