MAUDE Adverse Event Report: CARDINAL HEALTH ESTEEM STRETCHY SYNTH CREAM M; GLOVE, PATIENT EXAMINATION, VINYL

Catalog Number 8882B

Device Problem Reaction (1514)

Patient Problem Reaction (2414)

Event Date 02/12/2014

Event Type  Injury  

Event Description

Technologist reported breaking out in hives to the employee health department.She was examined by a physician and offered cortisone cream.Her reaction began months ago but was progressively getting worse.She is now using nitrile gloves without any problems.

Manufacturer Narrative

Cardinal health is filing as the importer.The device history record was reviewed and no abnormalities were noted.Historical trending was done.No sample was provided for evaluation.Based on the retained samples, there is no skin irritation after doing a wearing test.There is no change in the formulation and chemicals.Based on the investigation conducted, there is no abnormality found on the retained samples.Without the actual sample, the root cause cannot be determined.The supplier has been apprised of the complaint for close monitoring of the manufacturing process.We will continue to monitor for complaints of this nature.Notation - the customer stated that her reaction began months ago and did not provide an actual incident date.The cardinal health aware date of (b)(6) 2014 was used as the incident date on this report.

• Brand Name: ESTEEM STRETCHY SYNTH CREAM M
• Type of Device: GLOVE, PATIENT EXAMINATION, VINYL
• Manufacturer (Section D): CARDINAL HEALTH; mcgaw park IL 60085
• Manufacturer (Section G): CARDINAL HEALTH 200, LLC; 1430 waukegan rd; waukegan 60085
• Manufacturer Contact: michele donatich ; 1430 waukegan road; mcgaw park, IL 60085 ; 8478876412
• MDR Report Key: 3667070
• MDR Text Key: 21807455
• Report Number: 1423537-2014-00010
• Device Sequence Number: 1
• Product Code: LYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2014,03/07/2014

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: Other
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 8882B
• Device Lot Number: 9R13L029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/12/2014
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2014
• Initial Date Manufacturer Received: 02/12/2014
• Initial Date FDA Received: 03/07/2014
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 69