PDS Z338HRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031060586), received between Mar 19, 2022 and Mar 19, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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.

• InjuryMar 19, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED ON THE DEEP DERMAL LAYER. THE PATIENT WAS POSITIVE FOR CORONA OMICRON. THE WOUND WAS OPENED 8 TO 10 DAYS AFTER SURGERY. WHEN IT WAS CHECKED, THE SUTURE SITE OF THE UTERINE WOUND WAS NOT BROKEN, BUT THERE WAS NO SUTURE IN THE FASCIA MUSCLE LAYER AND DERMAL WOUND, AND THE WOUND WAS DEHISCENT. ONLY THE FIRST AND LAST LIGATION POINTS REMAINED, BUT THE MIDDLE SUTURE WAS COMPLETELY DISAPPEARED. THE SIZE OF THE INCISION WAS APPROXIMATELY 15 CM. RE-SUTURING WAS PERFORMED. THE ONLY DIFFERENCE FROM THE PAST WAS THAT AN ANTIBODY COCKTAIL, RONAPREVE, WAS ADMINISTERED BECAUSE THE PATIENT WAS A CORONA PATIENT. THE PATIENT HAS BEEN DISCHARGED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 13826824 ↗