Magic3 Hydrophilic Intermittent Catheter, MaleRecalls & reported problems across all models

We found 2 models of Magic3 Hydrophilic Intermittent Catheter, Male by Rochester Medical Corporation in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2017 and Jun 24, 2022 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Kinked” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Magic3 Hydrophilic Intermittent Catheter, Male problems

Magic3 Hydrophilic Intermittent Catheter, Male models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Magic3™ Hydrophilic Intermittent Catheter, Male 53614GS

  Catheter care tray
  21 reports
• Magic3™ Hydrophilic Intermittent Catheter, Male 53616GS

  Catheter care tray
  2 reports

Recent Magic3 Hydrophilic Intermittent Catheter, Male adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE COLLECTION BAG WAS MISSING FROM INTERMITTENT CATHETER KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14800531 ↗
• MalfunctionFeb 5, 2021Device Damaged Prior to Receipt by User; Expiration Date Error; Device Damaged Prior to Receipt by User; Expiration Date Error

  IT WAS REPORTED THAT THE CATHETER PACKAGING LABEL HAD THE INCORRECT EXPIRATION DATE AS 05/05/19, AND THE ACTUAL EXPIRATION DATE AS PER THE SYSTEM WAS 11/27/22 AND HAD SHORT COUNT SHIPMENT.

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

  MAUDE report 11285152 ↗
• MalfunctionFeb 4, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE CATHETER PACKAGING LABEL HAD THE INCORRECT EXPIRATION DATE AS (B)(6) 2019, AND THE ACTUAL EXPIRATION DATE INDICATED IN THE SYSTEM WAS (B)(6) 2022. PER NOTIFICATION FROM INVESTIGATOR ON (B)(6) 2021, THE CORRECT EXPIRATION DATE WAS PLACED ON THE CATHETER PACKAGING LABEL. IT WAS JUST SHIPPED TO THE CUSTOMER EXPIRED.

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

  MAUDE report 11279648 ↗
• MalfunctionOct 10, 2019Material Twisted/Bent

  IT WAS REPORTED THAT THE MAGIC 3 CATHETERS WERE BENT AND TWISTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9174955 ↗
• MalfunctionOct 8, 2019Material Twisted/Bent

  IT WAS REPORTED THAT THE MAGIC 3 CATHETERS WERE BENT AND TWISTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9168350 ↗
• MalfunctionOct 7, 2019Material Twisted/Bent; Packaging Problem

  IT WAS REPORTED THAT THE FIRST INCH OF THE CATHETERS WERE BENT DUE TO BAD PACKAGING. THIS RESULTED IN THE PATIENT EXPERIENCING SELF LIMITED BLEED DURING INSERTION OF THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 9161888 ↗
• MalfunctionJul 10, 2019Material Twisted/Bent

  IT WAS REPORTED THAT SOME OF THE CATHETERS WERE BENT. IT WAS LATER REPORTED PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONTACT VIA PHONE ON 02JUL2019, THE CATHETERS WERE FOLDED IN HALF INSIDE THE PACKAGING AND WERE STILL BENT WHEN THEY WERE REMOVED. THE PATIENT REPORTEDLY EXPERIENCED PAIN ONCE THE CATHETER WAS INSERTED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient; Pain

  MAUDE report 8776179 ↗
• MalfunctionJun 21, 2019Short Fill; Burst Container or Vessel; Short Fill; Component Missing

  IT WAS REPORTED THAT 10 OF THE CATHETERS HAD BURST PACKETS THAT HAD NO SOLUTION AND THE PATIENT DID NOT USE THEM. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8722711 ↗
• MalfunctionMay 15, 2019Difficult to Insert; Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS NOT ENOUGH LUBRICATION ON SOME OF THE CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8612460 ↗
• MalfunctionJul 9, 2018Product Quality Problem; Material Integrity Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS NOT ENOUGH LUBRICANT ON THE MAGIC 3 CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7670599 ↗
• MalfunctionApr 23, 2018Product Quality Problem; Difficult to Insert; Product Quality Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO FULLY INSERT THE CATHETER AFTER LETTING THE CATHETER SIT FOR 30 SECONDS IN THE LUBRICATION. THE PATIENT REPORTEDLY ADDED LUBRICATION THAT HE PURCHASED AND WAS ABLE TO INSERT THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7452578 ↗
• MalfunctionApr 23, 2018Product Quality Problem; Product Quality Problem; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO FULLY INSERT THE CATHETER AFTER LETTING THE CATHETER SIT FOR 30 SECONDS IN THE LUBRICATION. THE PATIENT REPORTEDLY ADDED LUBRICATION THAT HE PURCHASED AND WAS THEN ABLE TO INSERT THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7452500 ↗
• MalfunctionDec 6, 2017Bent

  IT WAS REPORTED THAT THE CATHETER WAS BENT, WHICH PUT PRESSURE ON THE URETHRA AFTER INSERTION.

  Patient problems: Discomfort

  MAUDE report 7087017 ↗
• MalfunctionOct 24, 2017Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY. THE PATIENT REPORTEDLY EXPERIENCED SELF LIMITED BLEEDING AFTER USE.

  Patient problems: Blood Loss

  MAUDE report 6973137 ↗
• MalfunctionAug 22, 2017Kinked; Folded

  IT WAS REPORTED THAT THE CATHETER WAS FOLDED IN HALF INSIDE THE PACKAGING, WHICH CAUSED A KINK AND MADE THE PRODUCT UNUSABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6810976 ↗