Zenapro G23770Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002237701), received between Aug 30, 2017 and Aug 30, 2017 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2017Insufficient Device Problem Information

  ON (B)(6) 2017, DR. (B)(6) PLACED A C-HYB-20X30 TO REPAIR A RECURRENT HERNIA. THE PREVIOUSLY PLACED ZENAPRO WAS NOT EXPLANTED. THE NEW ZENAPRO WAS PLACED IN THE ONLAY SPACE WITH THE 2-LAYER SIDE DOWN AND THE 4-LAYER SIDE UP. MANY (30+) PROLENE SUTURES WERE USED IN A RUNNING STITCH WITH A FEW INTERRUPTED STITCHES. TWO DRAINS WERE PLACED. THE DRAINS WERE LEFT IN PLACE FOR TWO MONTHS AND WERE REMOVED IN (B)(6). WITHIN A WEEK, THE PATIENT RETURNED WITH COMPLAINTS OF PAIN. A LARGE SEROMA WAS IDENTIFIED. THE SEROMA WAS DRAINED BY INTERVENTIONAL RADIOLOGY VIA A PERCUTANEOUS DRAINAGE. THE PATIENT WAS SEEN BY DR. (B)(6) THE WEEK OF (B)(6) 2017 AND WAS DRAINING QUESTIONABLE FLUID. A CULTURE OF THE FLUID WAS POSITIVE FOR AN UNSPECIFIED INFECTION. ON (B)(6) 2017, DR. (B)(6) REOPERATED ON THE PATIENT. THE 2-LAYER SIDE OF THE ZENAPRO, WHICH WAS THE POSTERIOR SIDE, WAS NOT INCORPORATED AND IT WAS SLIMY. THE 4-LAYER SIDE OF THE ZENAPRO WAS FULLY INCORPORATED. THE ZENAPRO WAS NOT EXPLANTED, BUT A DEBRIDEMENT OF THE 2-LAYER SIDE WAS PERFORMED. A WOUND VAC WAS PLACED ON THE PATIENT.

  Patient problems: Discharge; Pain; Seroma

  MAUDE report 6831529 ↗