Skip to content

Word G55442Recalls & reported problems

Cook Incorporated · Word Catheter Silicone Bartholin Gland Balloon · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002554429), received between Jan 29, 2019 and Jul 29, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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

  • Deflation Problem1
  • Material Rupture1
  • Migration1

Patient problems

  • No Consequences Or Impact To Patient1
  • Scar Tissue1

Recent adverse event reports

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

  • MalfunctionJul 29, 2019Material Rupture; Material Rupture

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8837981 ↗
  • InjuryJan 29, 2019Deflation Problem; Migration; Deflation Problem; Migration

    IT WAS REPORTED THAT DURING THE COURSE OF TREATMENT FOR BARTHOLIN GLAND ABSCESS, THE PATIENT HAD A WORD CATHETER SILICONE BARTHOLIN GLAND BALLOON PLACED ON (B)(6) 2018. THE DEVICE PLACEMENT LOCATION WAS UNSPECIFIED. ON (B)(6) 2019, 31 DAYS AFTER THE DEVICE WAS PLACED, THE DEVICE WAS REMOVED BY THE PHYSICIAN. IT IS REPORTED THAT WHEN THE PHYSICIAN PROCEEDED TO REMOVE THE DEVICE, THE WOUND HAD CLOSED. THE PHYSICIAN HAD TO MAKE A NEW INCISION TO ACCESS AND REMOVE THE BALLOON. IT IS REPORTED THAT THE BALLOON WAS FOUND DEFLATED AND HAVING MIGRATED INTO THE CYST CAVITY. THE PATIENT'S OUTCOME POST PROCEDURE IS UNKNOWN AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE ORIGINAL PLACEMENT LOCATION OF THE DEVICE, AS WELL AS OTHER PERTINENT DETAILS REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. PRECAUTION LISTED ON THE INSTRUCTIONS FOR USE (IFU): EPITHELIZATION TIME MAY VARY DEPENDING ON EACH PATIENT. THE WORD CATHETER-SILICONE BARTHOLIN GLAND BALLOON IS NOT INTENDED TO BE LEFT INDWELLING FOR PERIODS OF TIME GREATER THAN TWENTY-EIGHT (28) DAYS. INSTRUCTIONS FOR USE INCLUDE: CLEAN AREA SURROUNDING BARTHOLIN GLAND

    Patient problems: Scar Tissue

    MAUDE report 8284530 ↗

Other INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC devices

All INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC devices →

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