MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; JELLY,LUBE,STRL,FLIP TOP,TUBE,2 OZ

Catalog Number CTR000302

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Syncope (1610); Laceration(s) (1946); Nausea (1970)

Event Date 07/24/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient experienced an anaphylactic reaction from the lubricating jelly that was used during a prostate biopsy.Reportedly, during the procedure the patient experienced nausea, lightheadedness, and disorientation.After the procedure was completed, the patient experienced a syncopal episode with facial laceration and "hives over his entire body and also had throat and mouth swelling with shortness of breath." the patient reportedly went to a local hospital emergency department (ed) where he received an unknown number of sutures for his facial laceration, iv benadryl, and an unidentified steroid.No ed diagnostics reported.No additional ed treatments reported.It was not identified if the patient was admitted to the hospital after the ed visit.No sample was returned to the manufacturer for evaluation.A root cause could not be determined.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the patient experienced an anaphylactic reaction and a syncopal episode with facial laceration after use of the lubricating jelly for a prostate biopsy.

• Type of Device: JELLY,LUBE,STRL,FLIP TOP,TUBE,2 OZ
• 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: 7756354
• MDR Text Key: 116217328
• Report Number: 1417592-2018-00082
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CTR000302
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/07/2018
• 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: 60 YR
• Patient Weight: 79