MAUDE Adverse Event Report: TEPHA, INC. GALASHAPE 3D; GALAFLEX MESH, PRODUCT CODE: OOD

Model Number	100042-06
Medical Device Problem Codes	Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	05/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date on (b)(6) 2017, explant date on (b)(6) 2017; physician performed a culture of the infected tissue and confirmed growth of pseudomonas aeruginosa.Review of dhr (device history record) on part number 100042-06, lot number 160486 resulted in verification that there were no non-conformities documented for this lot.The sterilization cycle report was reviewed and the cycle met all acceptance criteria.
Event or Problem Description
Infection of breast, requiring removal.

• Brand Name: GALASHAPE 3D
• Common Device Name: GALAFLEX MESH, PRODUCT CODE: OOD
• Manufacturer (Section D): TEPHA, INC.; 99 hayden avenue; suite 360; lexington MA 02421
• MDR Report Key: 7024727
• Report Number: 3005670760-2017-00015
• Device Sequence Number: 19168786
• Product Code: OOD
• UDI-Device Identifier: 00855920006195
• UDI-Public: 01008559200061951717070710160486
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2017

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: 07/07/2017
• Device Model Number: 100042-06
• Device Catalogue Number: SH3D06
• Device Lot Number: 160486
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 11/13/2017
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 86