Woven Phillips Follower Urethral Catheter 021508Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741072932), received between Sep 9, 2020 and Sep 9, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionSep 9, 2020Expiration Date Error; Inaccurate Information; Expiration Date Error

  IT WAS REPORTED THAT THE EXPIRATION DATE ON THE BACK LABEL OF THE PRODUCT DID NOT MATCH WITH THE DATE ON THE ANALYTICAL CERTIFICATE. CERTIFICATE EXPIRATION DATE LOT: GFDP1338, REF: 021508, EXP. DATE. 31-MAR-2024. LABEL EXPIRATION DATE LOT: GFDP1338, REF: 021508, EXP. DATE. APR-2024. IT WAS ALSO STATED THAT THE LABEL TO THE CUSTOMER WAS REFERRED IN SPANISH. ACCORDING TO THE QUALITY TEAM IN MEXICO: THIS LABEL IS APPLIED ON THE DC IN MEXICO, ACCORDING TO THE NATIONALIZATION PROCESS BASED ON MEXICAN REGULATION. THE INFORMATION OF EXPIRATION DATE THAT GOES ON THIS LABEL, COMES FROM SAP. HOWEVER FOR LEGACY BARD PRODUCTS THE INFORMATION INSERTED IN SAP IS DONE MANUALLY. THE ANALYTICAL CERTIFICATE COMES FROM THE MANUFACTURING PLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10511084 ↗