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

Lot Number 796C, 960C

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

An adverse event was called in from the customer for an end user.The customer called for their daughter who used sterile lubricating jelly in a kit for a ventilator.The daughter has multiple infections which is not a normal occurrence.The lot numbers provided do not match h and p industries, inc.Lot numbers or product numbers.Multiple attempts have been made to obtain product information to verify the adverse event unsuccessfully.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: 17532219
• MDR Text Key: 321080494
• Report Number: MW5139127
• 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: 05/25/2011

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
• Device Lot Number: 796C, 960C
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1