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Sharpoint Plus R497NRecalls & reported problems

Surgical Specialties México, S. de R.L. de C.V. · PDO 3-0 Violet 1x18" PS-2 · Class 2 · Implant

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 00848782033065), received between May 27, 2022 and May 27, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Slipped” (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

Device problems

  • Device Slipped1

Patient problems

  • Inflammation1
  • Swelling/ Edema1

Recent adverse event reports

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

  • InjuryMay 27, 2022Device Slipped

    SURGERIES PERFORMED WITH PDO HAVE RESULTED IN SIGNIFICANT INFLAMMATION. I THOUGHT SOME WAS DUE TO KNOT SLIPPAGE AND NECESSITY OF PLACING A 4TH ROW AND PERHAPS WITH SLIPPAGE, THE OVERTIGHTENING OF THE WOUND. I OBSERVED SWOLLEN WOUNDS PARTICULARLY WITH 3-0 PDO.

    Patient problems: Inflammation; Swelling/ Edema

    MAUDE report 14523475 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.