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

Catalog Number 2D72PL70X

Device Problem Biocompatibility (2886)

Patient Problems Hypersensitivity/Allergic reaction (1907); Local Reaction (2035)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

The lot# was provided, therefore the device history record was reviewed.The lot was inspected and released in compliance with all requirements.There was no sample, however this person¿s patch test was positive for an allergy to carba mix, and this glove contains carba mix.The protexis pi classic 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 used during the manufacturing process cannot be ruled out.We will continue to monitor complaints for any unfavorable trends, which might require further investigation.

Event Description

Xray tech had initially called regarding obtaining glove ingredients if needed.She was getting blisters on her hands for the past 2 months, but was not sure what was causing her symptoms.She had been using the gloves for about a year but her symptoms were recent.She had seen a pa twice and a dermatologist ¿ they were going through the products she uses to try and identify the cause.On (b)(6) 2018 she called stating her patch testing showed she was allergic to carba mix.Her hands are doing better.

• Brand Name: GLOVE SURGICAL PROTEXIS PI CLASSIC
• 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 ; 8478874151
• MDR Report Key: 7917990
• MDR Text Key: 122003480
• Report Number: 1423537-2018-00240
• Device Sequence Number: 1
• Product Code: KGO
• UDI-Device Identifier: 10885380031779
• UDI-Public: 10885380031779
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 2D72PL70X
• Device Lot Number: TS18030372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2018
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 77