T-Line Hernia Mesh TL1507Recalls & reported problems
Deep Blue Medical Advances, Inc. · T-Line Hernia Mesh, 13.5cm x 5.5cm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850002394009), received between Apr 11, 2023 and Apr 11, 2023 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Itching Sensation1
- Rash1
- Skin Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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.
Patient problems: Itching Sensation; Rash; Skin Infection
MAUDE report 16721473 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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