SurgiMesh Tintra OK-1522Recalls & reported problems
Bg Medical, LLC · Class 2 · Implant
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 00850011929124), received between Apr 21, 2023 and Apr 21, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
AN MDR REPORT # MW5115459 WAS RECEIVED BY SUPPLIER/MANUFACTURING PARTNER MEDICAL MURRAY FROM FDA, AND SUBMITTED TO CHAMBERLAIN TECHNOLOGIES' DISTRIBUTOR (B)(4) ON 23-MAR-2023. THE DESCRIPTION OF THE MDR STATED "SURGIMESH PLACED ON (B)(6) 2021, INFECTION IDENTIFIED (B)(6) 2021. 1 YEAR TREATMENT WITH INFECTIOUS DISEASE, SURGEON, ANTIBIOTIC THERAPY. MESHED WAS REMOVED (B)(6) 2023. CT(COMPUTED TOMOGRAPHY) ABDOMEN: LARGE ABDOMINAL WALL FLUID COLLECTION UNDERLYING THE SURGICAL MESH. MEASURING 5.9 X 10.2 APPROXIMATELY. DRAIN PLACED" MESH WAS EXPLANTED ON (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 16789201 ↗
Other Mesh, Surgical, Polymeric devices
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- PROCEED PCDN1Johnson & Johnson International Inc. · Mesh, surgical, polymeric744 reports
- PROCEED PCDG1Johnson & Johnson International Inc. · Mesh, surgical, polymeric1 recall1 death637 reports
- PROCEED PVPSJohnson & Johnson International Inc. · Mesh, surgical, polymeric622 reports
- ProGrip LPG1510Sofradim Production · Mesh, surgical, polymeric2 deaths616 reports
- VENTRALEX 0010302Davol Inc. · Mesh, surgical, polymeric4 deaths531 reports
- BARD 0112680Davol Inc. · Mesh, surgical, polymeric1 death494 reports
- ProGrip TEM1509GSofradim Production · Mesh, surgical, polymeric3 deaths471 reports
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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