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 Unspecified Infection (1930)

Event Date 12/01/2010

Event Type  Injury  

Event Description

An adverse event was called in from the customer for an end user.The customer had a procedure on (b)(6) 2010 in which lube jelly was used and she had a possible reaction.The reporting customer said they do not have a record of the lot code and was not sure if the reaction was due to the lube jelly or other changes in medication.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 (b)(4).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: 17528549
• MDR Text Key: 321051829
• Report Number: MW5135479
• 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

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1