MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER,MALE,EXTERNAL,SIL,SM, T1, 25MM

Catalog Number DYND23400

Device Problem Material Deformation (2976)

Patient Problems Tissue Breakdown (2681); Skin Inflammation/ Irritation (4545)

Event Date 03/27/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, the condom catheters will not "completely unroll" causing "a red ring/irritation".The customer reported patients' skin damage are "equivalent to stage 2 wound" requiring "wound care, barrier paste twice daily, and wound care following up on injury".The sample has been requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, the condom catheters will not "completely unroll" causing "a red ring/irritation".

• Type of Device: CATHETER,MALE,EXTERNAL,SIL,SM, T1, 25MM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16795683
• MDR Text Key: 313826446
• Report Number: 1417592-2023-00181
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYND23400
• Device Lot Number: 59222102413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other