MAUDE Adverse Event Report: COLOPLAST HUNGARY MALE EXTERNAL CATHETER

Catalog Number 5057111400

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Urinary Tract Infection (2120)

Event Date 01/23/2023

Event Type  Injury  

Event Description

It was reported that the urine was not draining from the external and just sitting in the catheter, also stated that this caused the patient to get a uti and that the patient had not used this particular external before.It was unknown what medical intervention was provided.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be "mechanical failure".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿intended purpose urisheaths/male external catheters are intended to drain urine, normally into a urinary collection bag.Indications: male external catheter.Warnings: re-use of this single use product is not recommended as cross contamination may occur.Reprocessing, washing, disinfection and/or (re)sterilization may compromise product characteristics, causing additional risk of physical harm or infection to the user.Cautions: do not use with alcohol-based skin preparations unless thoroughly dry.Residual alcohol may cause degradation of material or excessive adhesion to skin.Information: this is a single use product.The sheath/catheter is self-adhesive.The device does not have to be removed before a mr scan as it is mr safe.The product is not made with natural rubber latex, however rare contamination with trace amounts of natural rubber latex during manufacturing or packaging may occur.Do not use with creams and powders.Using these products with the sheath/ catheter could stop the adhesive from working effectively.If you experience a suspected allergic reaction or any other side effects, please contact your healthcare professional.Coloplast accepts no liability for any injury or loss that may arise if this product is used in a manner contrary to coloplast's current recommendations.How to use: preparation: trim pubic hair if necessary.Wash the penis with soap and water.Dry thoroughly.Application: when applying the product, leave the foreskin in place over the head of the penis to prevent tangling or pulling of the loose skin.This applies to uncircumcised men.If circumcised, this instruction does not apply.Place the rolled sheath/catheter over the head of the penis with the narrow end pointing away from the body.Leave a 0.4-0.8 in.(1-2 cm) gap between the tip of the penis and the narrow outlet tube to allow the free flow of urine.Slowly unroll the product to its full length, or to the length of the penis.Gently squeeze the unrolled sheath/catheter around the shaft of the penis to ensure adhesion to the skin and to seal off any wrinkles.No additional adhesive is necessary.Attach the product to a urine collection bag.The urinary collecting system is now functional.Removal: disconnect the product from the urine collection bag.Grasp the sheath/catheter at the base and roll forward gently.Disposal: change the product according to local guidelines and recommendations.Each product should be worn for no longer than 24 hours.Skin maintenance: if possible, allow the skin to breathe for short periods between product changes.The product is intended for single use only and should be disposed of in accordance with local guidelines, e.G.With normal household waste.Do not flush the product down the toilet.Reporting of incidents: if, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and to your national authority.¿ the device was not returned.

• Brand Name: MALE EXTERNAL CATHETER
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): COLOPLAST HUNGARY; holtedam 1; 3050 humlebaek; DA
• MDR Report Key: 16395935
• MDR Text Key: 309747665
• Report Number: 1018233-2023-00960
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5057111400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/23/2023
• Event Location: Other
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male