MAUDE Adverse Event Report: DEEP BLUE MEDICAL ADVANCES, INC. T-LINE HERNIA MESH

Model Number	TL1507
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033); Skin Infection (4544)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 3/8/2023, an email inquiry from the deep blue website from a bh asking for the deep blue phone number so he could file an adverse event.Additionally, on the same day mr.Perry, deep blue's ceo contacted dr.Saxe.Dr.Saxe confirmed that bh is a patient of his.He stated that bh had redness and itchiness on his skin over a large part of his abdomen.He mentioned the patient had no pain, only itchiness of the skin.He mentioned the patient was healing well from the surgery and did not have any issues with infection or surgical healing that he could tell.He wondered if it was an allergic reaction to polypropylene.He was going to follow-up on the patient and see how it progressed.
Additional Manufacturer Narrative
After further investigation including review of manufacturing records and interviews with the patient and their doctor, it was determined to be a streptococcus infection at the site of the incision.The patient's medication was changed and as of a follow up with the doctor on (b)(6) 2023, the doctor stated that the patient is responding very well to the antibiotics.He further stated that he did not believe the infection was due to any mesh allergy or other mesh issue, and that it will resolve completely with the antibiotics.

• Brand Name: T-LINE HERNIA MESH
• Common Device Name: HERNIA MESH
• Manufacturer (Section D): DEEP BLUE MEDICAL ADVANCES, INC.; 701 w main street; suite 410; durham NC 27701
• Manufacturer (Section G): SANAVITA MEDICAL; 551 church rd; telford PA 18969
• Manufacturer Contact: lou fuqua ; 701 w main street # 410; durham, NC 27701 ; 8338333725
• MDR Report Key: 16721473
• Report Number: 3017492634-2023-00001
• Device Sequence Number: 7387415
• Product Code: FTL
• UDI-Device Identifier: 00850002394009
• UDI-Public: (01)00850002394009(10)A2112002(17)240528
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K221556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2023

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: 05/28/2024
• Device Model Number: TL1507
• Device Catalogue Number: TL1507
• Device Lot Number: A2112002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic