SURGIMESH®WN T1015-8Recalls & reported problems
Aspide Medical · Non woven, non knitted reinforcement material made from polypropylene. · 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 03700296902893), received between Dec 28, 2018 and Dec 28, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility1
Patient problems
- Patient Problem/Medical Problem1
- Wound Dehiscence1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 28, 2018Patient-Device Incompatibility
WE WERE INFORMED BY THE COMPANY "ETHICON" THAT THEY RECEIVED THE FOLLOWING EVENT: IT WAS REPORTED BY THE NURSE PRACTITIONER THAT THE PATIENT HAD A HERNIA REPAIR ON (B)(6) 2018 AND HAS HAD IMPAIRED WOUND HEALING AND A WOUND VAC, DUE TO WOUND DEHISCENCE. THE CUSTOMER STATES A STRAP25 DEVICE & SURGIMESH- MESH PRODUCT WAS USED IN THE PROCEDURE. NURSE PRACTITIONER ALSO REPORTED PATIENT EXPERIENCED AN ALLERGIC REACTION TO MESH USED IN HERNIA REPAIR, SURGIMESH, LOT F14441A REF (B)(4), UNKNOWN IF ANY PRODUCT IS AVAILABLE FOR TESTING.
Patient problems: Patient Problem/Medical Problem; Wound Dehiscence
MAUDE report 8202958 ↗
Other Mesh, Surgical, Polymeric devices
- PROCEED PVPMJohnson & Johnson International Inc. · Mesh, surgical, polymeric1,233 reports
- 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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