MAUDE Adverse Event Report: CARDINAL HEALTH MALAYSIA 211 SDN.BHD GLV EXAM PF SYN ESTEEM W/NEU-THERA SZ SM; VINYL PATIENT EXAMINATION GLOVE

Model Number S88RX02

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 03/14/2017

Event Type  Injury  

Manufacturer Narrative

Historical trending for the past 12 months was completed: this is the 1st complaint for this glove type and failure mode.The device history record was reviewed and no abnormality noted. all manufacturing process control and operating parameters were within the validated specification and no abnormality was found.No change was made to the raw materials and suppliers, compounding formulation, or manufacturing process during the production of this lot.Pre-shipment quality inspection of this lot passed all inspection requirements prior to final shipment release.Returned complaint gloves did not exhibit any visible abnormality.The need for corrective and/or preventive actions will be determined once the complaint samples testing is completed.It is to be noted that sensitivity of individuals to synthetic/vinyl gloves may be a factor in developing or allergic reaction or skin irritation from wearing such gloves.The glove manufacturer will continue to ensure that the manufacturing process is stable as well as capable, good manufacturing practices are adhered to and continuous improvement strategies are implemented in order to ensure gloves are consistently produced according to the required specification prior to packing and release for shipment.

Event Description

Based on information received from the customer an employee was wearing gloves s88rx02.The employee then broke out in hives.The employee went to employee health and was provided benadryl.This was the first time the employee wore these gloves.  she is doing fine now.

Manufacturer Narrative

Returned complaint glove samples did not exhibit any visible abnormality and no allergic reaction or skin irritation was reported by the glove manufacturing plant personnel from donning the gloves at an-hour's stretch.Dermal irritation test returned a conclusion that the irritation of test substance is negligible on test sample skins and that the primary irritation index (pii) of test material was ¿0¿, which appears to rule out the possibility that the gloves could potentially cause allergic reaction or irritation upon contact with skin.It is to be noted that sensitivity of certain individuals to nitrile gloves may be a factor in developing allergic reaction or skin irritation from wearing such gloves.Manufacturing process was reviewed by the glove manufacturer to ensure it is running with the validated parameters and within normal process capability.  the glove manufacturer will continue to ensure that the manufacturing process is stable as well as capable, good manufacturing practices are adhered to and continuous improvement strategies are implemented to ensure gloves are consistently produced according to the required specification prior to packing and release for shipment.

• Brand Name: GLV EXAM PF SYN ESTEEM W/NEU-THERA SZ SM
• Type of Device: VINYL PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): CARDINAL HEALTH MALAYSIA 211 SDN.BHD; zone phase iv, mk 12 lintang ,; bayan lepas 11900 ; MY 11900
• Manufacturer (Section G): CARDINAL HEALTH MALAYSIA 211 SDN.BHD; zone phase iv, mk 12 lintang ,; bayan lepas 11900 ; MY 11900
• Manufacturer Contact: michele donatich ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6471591
• MDR Text Key: 72090788
• Report Number: 1423537-2017-00080
• Device Sequence Number: 1
• Product Code: LYZ
• UDI-Device Identifier: 10885380135408
• UDI-Public: 10885380135408
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2017

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: Speech Therapist
• Device Model Number: S88RX02
• Device Catalogue Number: S88RX02
• Device Lot Number: 4Y14J007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/14/2017
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 82