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BroadBand Loop CM-0305SNRecalls & reported problems

Riverpoint Medical, LLC · Suture · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810020081138), received between Jul 13, 2022 and Jul 13, 2022 — classified as 2 malfunctions.

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

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

  • Break2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 13, 2022Break; Break

    ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING SURGERY THE BROADBAND TAPE OF THE COMPLAINT PRODUCT WAS BROKEN WHILE THE SURGEON APPLIED TENSION TO THE BROADBAND TAPE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15009221 ↗
  • MalfunctionJul 13, 2022Break; Break

    ACCORDING TO THE REPORTER, "IT WAS REPORTED THAT DURING SURGERY, THE BROADBAND TAPE OF THE COMPLAINT PRODUCT WAS BROKEN WHEN THE SURGEN APPLIED TENSION TO THE BROADBAND TAPE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15009142 ↗

Other Suture, Nonabsorbable, Synthetic, Polyethylene devices

All Suture, Nonabsorbable, Synthetic, Polyethylene devices →

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