MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; UNDERWEAR,PROTECTIVE,SUPER,XXL,68-80"

Catalog Number MSC33700

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Unspecified Infection (1930)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the shipment of protective underwear that the end-user received was undersized.After an unidentified length of using the protective underwear that was received, the end-user reportedly became concerned of an infection and contacted her physician.According to the end-user the length of use of each protective underwear varied but it was no more than eight (8) hours.Reportedly, a home health care agent was sent to evaluate the end-user and obtain a urine sample.According to the end-user the urine sample identified blood in her urine and she was prescribed an unidentified "yeast infection medication." no protective underwear leaks, additional diagnostic exams/results, medical intervention, or follow-up care was reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the reported need for medical intervention, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the protective underwear was undersized and the end-user was prescribed "yeast infection medication.".

• Type of Device: UNDERWEAR,PROTECTIVE,SUPER,XXL,68-80"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 9191650
• MDR Text Key: 162644623
• Report Number: 1417592-2019-00169
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MSC33700
• Device Lot Number: C03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 125