MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; LINER,INCONTINENT,ULTRAPLUS,3.25"X13"

Catalog Number MSC327100Z

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Type  malfunction  

Manufacturer Narrative

It was initially reported that customer contact developed urinary tract infection related to use of bladder control pads.Per report, after the customer contact was told by her doctor to not use the bladder control pads since this resulted in urinary tract infection, customer contact gave the remaining bladder control pads to her granddaughter.Reportedly, the customer contact's granddaughter also developed urinary tract infection, which required unknown antibiotic therapy.Despite good faith efforts to obtain additional information, the initial reporter was unable or unwilling to provide any further information about her granddaughter, product, or event details.The customer contact stated that her granddaughter is doing well now.Due to the reported urinary tract infection and required medical intervention, this medwatch is being filed.The sample is not available to be returned for evaluation.The complaint could not be confirmed and a definitive root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that end-user developed urinary tract infection related to use of bladder control pads.

• Type of Device: LINER,INCONTINENT,ULTRAPLUS,3.25"X13"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8508911
• MDR Text Key: 145772829
• Report Number: 1417592-2019-00051
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MSC327100Z
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2019
• 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): Required Intervention
• Patient Age: 19 YR