MAUDE Adverse Event Report: CARDINAL HEALTH (THAILAND) 222 LIMITED GLOVE SURGICAL PROTEXIS NEOPRENE; SURGEON'S GLOVES

Catalog Number 2D73DP65

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Rash (2033); Burning Sensation (2146)

Event Date 01/12/2018

Event Type  Injury  

Manufacturer Narrative

The device history record of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.Historical trending was done.At this time, the samples appear to be in transit and have not been received by the manufacturing site.If samples are received by the manufacturing site, a follow up report will be filed.Photos were provided and showed a rash on hands and wrists.The protexis neoprene gloves passed the requirements of the primary skin irritation test per the technical service report.There have been no changes to the glove formulation or production process.The actual root cause could not be determined.The protexis neoprene gloves have passed a series of tests prescribed by regulatory agencies for the intended use.However, the possibility of some individuals experiencing reactions to certain chemicals that are used during the manufacturing process cannot be ruled out.There is no action plan at this time, however we will continue to monitor complaints for any unfavorable trends, which might require further investigation.

Event Description

Rn developed burning sensation both hands, red raised rash on second day of wearing the gloves (first day she felt irritated and burning sensation).She tried over the counter benadryl crème.When there was no relief after two days, she went to a physician and was prescribed prednisone 5mg x 5 days.

Manufacturer Narrative

The returned samples were evaluated by the primary skin irritation test, and the test result was a (b)(6).Therefore the actual root cause of the reported issue could not be determined.The protexis neoprene glove has had no change to the glove formulation or production process.Also, the protexis neoprene glove has passed a series of tests prescribed by regulatory agencies for the intended use.However, the possibility of some individuals experiencing reactions to certain chemicals used during the manufacturing process cannot be ruled out.We will continue to monitor complaints for any trends.

Manufacturer Narrative

Cardinal health has received the glove samples and they have been forwarded to an outside lab for further testing.Once the results have been received a follow up report will be submitted.

• Brand Name: GLOVE SURGICAL PROTEXIS NEOPRENE
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): CARDINAL HEALTH (THAILAND) 222 LIMITED; 7/111 moo 4 highway #331, maby; rayong 21140 ; TH 21140
• Manufacturer (Section G): CARDINAL HEALTH (THAILAND) 222 LIMITED; 7/111 moo 4 highway #331, maby; rayong 21140 ; TH 21140
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 7265110
• MDR Text Key: 99877349
• Report Number: 1423537-2018-00153
• Device Sequence Number: 1
• Product Code: KGO
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 2D73DP65
• Device Lot Number: TS17090522
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Weight: 66