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

Catalog Number 2D72PT70X

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

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Swelling (2091); Fluid Discharge (2686)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

Complaint forwarded to plant for investigation.Representative samples are in route to plant.Follow up report will be filed once samples are evaluated and the investigation completed.

Event Description

Pharmacy technician had an allergic reaction about 2 months ago from an undetermined cause (they suspected the surgical hand sanitizer or the glove).At that time the technician was removed from all duties requiring garbing for sterile compounding; and she was referred to an allergist and dermatologist.After treatment and clearance, on (b)(6) 2017 the tech was scheduled for a full eight hour shift that required garbing with the surgical gloves.Later that day her hands became red, swollen, weepy (almost twice their normal size), and difficult to make a closed fist.Since this was the second occurrence of the reaction and the technician had clear demarcation from her wrist to her fingernails, it was determined to be related to the gloves.The technician was pulled from all duties requiring the surgical gloves, resumed her prior topical treatment.Her skin is now dry, cracked, and flaking.

Manufacturer Narrative

Originally it was reported that the pharmacy technician experienced the reaction to catalog# 2d72pt60x, lot# ts16050054; and this is the information that was provided on the initial medwatch. since then however, it was learned that the actual catalog# involved is 2d72pt70x, lot# ts16090363. the manufacture date for this catalog number is (b)(6) 2016, and the expiration date is august 2019. the device history record of complaint lot ts16090363 was reviewed, and the lot was inspected and released in compliance with all requirements.Historical trending was done.A representative sample (unopened package) of catalog# 2d72pt70x / lot# ts16090363 was received and evaluated by visual inspection.The sample was submitted for primary skin irritation testing, and passed the test.The actual root cause could not be determined.The protexis pi gloves have passed a series of tests prescribed by regulatory agencies for the intended use.However the possibility of an individual experiencing a reaction to certain chemicals used during the manufacturing process cannot be ruled out.There has been no change to the glove formulation or production process.We will continue to monitor complaints for any trends which might require further investigation.

• Brand Name: GLOVE SURGICAL PROTEXIS PI
• 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: michele donatich ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6511656
• MDR Text Key: 73387665
• Report Number: 1423537-2017-00084
• Device Sequence Number: 1
• Product Code: KGO
• UDI-Device Identifier: 10885380127540
• UDI-Public: (01)10885380127540
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 2D72PT70X
• Device Lot Number: TS16090363
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR