MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; BRIEF,CLOTHLIKE,FITEXTRA,LG,48-58"

Catalog Number FITEXTRALGZ

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

Patient Problem Fungal Infection (2419)

Event Date 09/18/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the end-user used the incontinence briefs since (b)(6) 2018 (approximately six months) and end-user developed "red, round, flat" rashes to the perineal area.Per report, end-user required use of nystatin (anti-fungal) cream and skin protectant pastes.Reportedly, the end-user has no known allergies.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further end-user, product, or procedural details.No information was provided on what product problem or device failure was experienced with the incontinence briefs leading to the end-user developing fungal rash.Due to the reported medical intervention, this medwatch is being filed.Samples are not available to be returned for evaluation.A root cause could not be established at this time.No additional information is available.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that end-user developed fungal rash to the perineal area after using the incontinence briefs for six months.

• Type of Device: BRIEF,CLOTHLIKE,FITEXTRA,LG,48-58"
• 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: 8189103
• MDR Text Key: 131139628
• Report Number: 1417592-2018-00140
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: FITEXTRALGZ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR
• Patient Weight: 47