MAUDE Adverse Event Report: SGP01 SINGAPORE GLV EXAM NITRILE FLEXALTOUCH PF LG; PATIENT EXAMINATION GLOVE, SPECIALTY

Model Number 88RT04L

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

Based on supplier investigation, the device history record could not be reviewed, as the lot number was not provided.No sample was returned for the investigation.There is no occurrence reported in the past 12 months.No changes have been made to the manufacturing process and product formulation of the affected product.Supplier confirmed their product formulation does not contain any dialkylthioureas.Supplier initiated ph test on the retained samples from a random good shipment.The ph test had been conducted on 3 pieces of retained samples to determine the ph value of the gloves.The ph test results show that the gloves¿ ph values are within specification.Supplier had reviewed the biocompatibility test report (iso (b)(4) animal irritation test and dermal sensitization assay test) for the affected product.The tests concluded that the gloves were non-irritant and non-sensitizing.Based on the investigation and analysis made on the retained samples, no abnormality was found that could lead to the reported issue.All testing conducted proved that the gloves conform to the quality requirements.The root cause could not be determined for this case.No action will be taken at this time, we will continue to monitor for trends.

Event Description

Based on information received by the customer, the patient reportedly had an allergic reaction to dialkylthioreas.Hospital reported the information to see if cardinal health glove 88rt04l contains this product.The patient reportedly was given 50mg of benadryl via iv while intubated.The patient allegedly experienced hives on the torso after having been touched by the gloves.

• Brand Name: GLV EXAM NITRILE FLEXALTOUCH PF LG
• Type of Device: PATIENT EXAMINATION GLOVE, SPECIALTY
• Manufacturer (Section D): SGP01 SINGAPORE; 10 kallang avenue , #10-10/18; singapore 33951 0; SN 339510
• Manufacturer (Section G): SGP01 SINGAPORE; 10 kallang avenue , #10-10/18; singapore 33951 0; SN 339510
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 11041476
• MDR Text Key: 222636583
• Report Number: 1423537-2020-00579
• Device Sequence Number: 1
• Product Code: LZC
• UDI-Device Identifier: 10885380157363
• UDI-Public: 10885380157363
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 88RT04L
• Device Catalogue Number: 88RT04L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other