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

Catalog Number 8883B

Device Problem Reaction (1514)

Patient Problem Reaction (2414)

Event Date 01/30/2014

Event Type  Injury  

Manufacturer Narrative

Samples were received and the lot# was provided.The device history record was reviewed and no abnormalities were noted.Historical trending was done.Based on the returned samples, there was no skin irritation with the wearing test.There has been no change in the formulation of the glove.The supplier has been apprised of this reported incident for close monitoring of the manufacturing process.No corrective action will be taken at this time as we are unable to identify the root cause.We will continue to monitor complaints for any trends of this nature.

Manufacturer Narrative

Cardinal health is filing this as the importer.The complaint was forwarded to the manufacturing facility for investigation.We are awaiting sample return from the customer.When samples are received they will be forwarded to the manufacturing facility for investigation.A follow up report will be filed when the results of investigation are completed.

Event Description

Two nurses between the ages of 25-35 developed skin irritation and were seen by the infection nurse.They were given a cream (name not provided) and different gloves were bought for them.

• Brand Name: ESTEEM STRETCHY SYNTH CREAM L
• 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: 3650321
• MDR Text Key: 11586335
• Report Number: 1423537-2014-00009
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2014,03/26/2014

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: Nurse
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 8883B
• Device Lot Number: 9R13P052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2014
• Initial Date Manufacturer Received: 01/30/2014
• Initial Date FDA Received: 02/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR