MAUDE Adverse Event Report: CHESTER LABS, INC. EZ- LUBRICATING JELLY

Model Number 000304

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Itching Sensation (1943); Swelling (2091); Urticaria (2278); Reaction (2414)

Event Type  Injury  

Event Description

A physician's office reported that one patient experienced an allergic reaction on two separate occasions.The incidents occurred at different locations and an attempt was made to identify a potential source of the allergic response.A root cause was not confirmed but use of the lubricating jelly was common to both incidents.The first incident occurred in the office and was minor.The second reaction occurred during a colonoscopy and the pt developed itching, hives, swelling of the throat and shortness of breath.The symptoms resolved and it is not known if any medical intervention was initiated.The pt has known allergies to bee stings and various medications including but not limited to penicillin and possibly sulfa.No lot number was available for either product used.The patient is currently being followed by allergist.The patient's physicians have not confirmed the lube jelly caused or contributed to the allergic reaction but in an abundance of caution, this medwatch is being filed.

Manufacturer Narrative

Patient is seeing an allergist who wanted more info about ez lube jelly and that is why the physician's office contacted us.They requested literature, package info, and an ingredient statement.Chester packaging's customer service department forwarded a list of ingredients.In addition, an ingredient statement with package used instructions was also sent to the physician's office.The patient's allergist and physician's office have not confirmed that the lube jelly caused or contributed to the incident but chester packaging is filing this report in an abundance of caution.

• Brand Name: EZ- LUBRICATING JELLY
• Type of Device: LUBRICATING JELLY
• Manufacturer (Section D): CHESTER LABS, INC.; 1900 section rd., suite a; cincinnati OH 45237
• Manufacturer (Section G): CHESTER LABS, INC.; 1900 section rd., suite a; cincinnati OH 45237
• Manufacturer Contact: 1900 section rd., suite a; cincinnati, OH 45237 ; 5134583840
• MDR Report Key: 3731352
• MDR Text Key: 16797076
• Report Number: 1022110-2014-00001
• Device Sequence Number: 1
• Product Code: KMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 000304
• Device Catalogue Number: 000304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other