MAUDE Adverse Event Report: H AND P INDUSTRIES, INC. STERILE LUBRICATING JELLY; LUBRICANT, PATIENT

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

Patient Problem Urinary Tract Infection (2120)

Event Date 04/01/2010

Event Type  Injury  

Event Description

An adverse event was called in from the customer for an end user.The customer was using the lube jelly for self catherization in (b)(6) 2010 and developed a urinary tract infection.The reporting customer said they would pull the chart, when the chart was pulled there was no lot number recorded and the customer no longer has the product.At this time, it cannot be confirmed that the product is sterile lubricating jelly manufactured by h and p industries, inc.And distributed by the triad group.Complaint investigation call id (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STERILE LUBRICATING JELLY
• Type of Device: LUBRICANT, PATIENT
• Manufacturer (Section D): H AND P INDUSTRIES, INC.
• MDR Report Key: 17532241
• MDR Text Key: 321080901
• Report Number: MW5139149
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1