MAUDE Adverse Event Report: TEPHA, INC GALAFLEX¿ SCAFFOLD; SURGICAL MESH

Model Number	100035-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing records indicated the product was produced to and met specifications.The sterilization cycle was reviewed and all parameters met specifications.Physician confirmed product packaging was undamaged and intact.The surgeon felt that the mrsa was community-acquired (or potentially due to patient colonization) and not hospital acquired.He believes that the bacteria colonized the mesh/implant site through the drains site once she left the hospital, as this provided a direct conduit for bacteria.The infection has resolved.
Event or Problem Description
The surgeon reported that patient developed left breast infection 10 days post-op with mrsa.Temperature at 102f, requiring urgent removal of breast implant and mesh.Surgery to remove left breast implant and mesh occurred on (b)(6) 2019.The patient then developed symptoms in the right breast.Additional surgery to remove right breast implant and mesh occurred on (b)(6) 2019.Infection was determined to be likely community-acquired at the drains that were implanted.

• Brand Name: GALAFLEX¿ SCAFFOLD
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): TEPHA, INC; 99 hayden ave; lexington MA 02421
• MDR Report Key: 8445505
• Report Number: 3005670760-2019-00005
• Device Sequence Number: 2893635
• Product Code: OOD
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

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: 07/31/2019
• Device Model Number: 100035-15
• Device Catalogue Number: GP0408
• Device Lot Number: 170202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BILATERAL BREAST IMPLANTS AND DRAINS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Weight: 45