MAUDE Adverse Event Report: TEPHA, INC GALAFORM¿ SCAFFOLD 3D; SURGICAL MESH

Model Number	100043-06
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing and sterilization records was performed and found that the lot was manufactured to and met all specifications and the sterilization cycle met validated parameters.No conclusion can be made.As reported, the reason for the mycobacterium infection could not be determined based on the information provided.M.Abscessus is a bacterium part of a group of environmental mycobacteria and is found in water, soil, and dust.It has been known to contaminate medications and products, including medical devices.M.Abscessus can cause a variety of infections.Healthcare-associated infections due to this bacterium are usually of the skin and the soft tissues under the skin.People with open wounds or who receive injections without appropriate skin disinfection may be at risk for infection by m.Abscessus.At this time, we are unable to determine to what degree, if any, the mesh implant used on the patient may have caused or contributed the patient's condition.Infection is a known inherent risk of surgery with or without the use of mesh.If additional information is provided, an emdr will be submitted.Tepha has made several attempts to obtain additional information, however the reporter / complainant was unable or unwilling to provide any further information on the patient, product or procedural details.
Event or Problem Description
Doctor stated the patient developed a "mycobacterium abscessus" infection after the initial surgery and had to be on steroids and antibiotics for 6 months.He removed the mesh and the infection came back again.No additional information provided.

• Brand Name: GALAFORM¿ SCAFFOLD 3D
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): TEPHA, INC; 99 hayden ave; lexington MA 02421
• MDR Report Key: 8445508
• Report Number: 3005670760-2019-00003
• Device Sequence Number: 16865682
• Product Code: OOD
• UDI-Device Identifier: 00855920006270
• UDI-Public: (01)00855920006270(17)181105(10)170503
• 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: 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): 03/12/2019

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: 11/05/2018
• Device Model Number: 100043-06
• Device Catalogue Number: FR3D06
• Device Lot Number: 170503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Weight: 68