PDS Z489GRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031061132), received between Mar 6, 2019 and Oct 19, 2023 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Aug 10, 2023Open, Classified

   Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

   Z-2617-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023 AND SUTURE WAS USED. THE SUTURE WAS EASILY DETACHED DURING USE ON THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965367 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH A REACTION. THE PATIENT EXPERIENCED REDNESS, SWELLING AND ITCHING. NO SIGN OF INFECTION. THE SURGEON ADVISED THE PATIENT TO SEE AN ALLERGIST. THE PATIENT WAS PRESCRIBED STEROIDS. THE PATIENT IS STILL EXPERIENCING THE SWELLING BUT ARE SLOWLY IMPROVING. THE SUTURE HAS NOT BEEN REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Itching Sensation; Pain; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 17669397 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH A REACTION. THE PATIENT EXPERIENCED REDNESS, SWELLING AND ITCHING. NO SIGN OF INFECTION. THE SURGEON ADVISED THE PATIENT TO SEE AN ALLERGIST. THE PATIENT WAS PRESCRIBED STEROIDS. THE PATIENT IS STILL EXPERIENCING THE SWELLING BUT ARE SLOWLY IMPROVING. THE SUTURE HAS NOT BEEN REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Itching Sensation; Pain; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 17669394 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH A REACTION. THE PATIENT EXPERIENCED REDNESS, SWELLING AND ITCHING. NO SIGN OF INFECTION. THE SURGEON ADVISED THE PATIENT TO SEE AN ALLERGIST. THE PATIENT WAS PRESCRIBED STEROIDS. THE PATIENT IS STILL EXPERIENCING THE SWELLING BUT ARE SLOWLY IMPROVING. THE SUTURE HAS NOT BEEN REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Itching Sensation; Pain; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 17669393 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BLEPHAROPLASTY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH A REACTION. THE PATIENT EXPERIENCED REDNESS, SWELLING AND ITCHING. NO SIGN OF INFECTION. THE SURGEON ADVISED THE PATIENT TO SEE AN ALLERGIST. THE PATIENT WAS PRESCRIBED STEROIDS. THE PATIENT IS STILL EXPERIENCING THE SWELLING BUT ARE SLOWLY IMPROVING. THE SUTURE HAS NOT BEEN REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Itching Sensation; Pain; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 17669392 ↗
• MalfunctionJan 13, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING USE. ANOTHER PACKAGE WAS USED WITH NO PROBLEM. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9581766 ↗
• MalfunctionMar 6, 2019Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON (B)(6) 2019 A SUTURE WAS USED. THE SUTURE WAS BROKEN AT THE SWAGE PART DURING DERMOSTITCH BY CONTINUOUS SUTURING. IT WAS COMMENTED THAT NO EXTRA TENSILE STRENGTH WAS APPLIED TO THE SUTURE. FURTHER DETAILS ARE NOT PROVIDED THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8394366 ↗