MAUDE Adverse Event Report: SGP01 SINGAPORE GLV EXAM NITRILE FLEXAL COMFORT MD; PATIENT EXAMINATION GLOVE

Model Number 88FS03M

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

Patient Problem Reaction (2414)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

From the device history record, lot number 12p19a031 was manufactured in jan 2019.All the incoming raw materials, in-process quality assurance (qa) inspection and final inspections have been completed.As per investigation, in-process qa (ipqa) and pre-shipment qa (psqa) have performed the buy off inspection process and passed within the specification limits based on the random sampling plan.No deviation was raised on the incoming, in-process or final stages of the product.No sample returned for investigation.There were no changes in the process, production, machine, and raw materials used during the manufacturing process.Additionally, the gloves have been tested through dermal sensitization test and primary skin irritation test.There were no any abnormalities observed during the test performed.The operating parameters were within the validation range.The pre-leaching and post-leaching tds reading for all ripping machine involved were well within the specification.Besides, the pre-shipment inspection results indicated that the product under the lot number has met the specified requirement per product specification and release criteria before released for shipment.From the investigation, the root cause could not be determined.Therefore, no action will be taken at this time, we will continue monitoring our customer complaints data base for this and any other issues reported of the same nature.

Event Description

Based on information received from the customer allegedly the employees¿ hands are breaking out due to using the gloves.The employee was reportedly seen by her physician and prescribed transdermal steroid cream.

Manufacturer Narrative

from the device history record, lot number 12p19a031 was manufactured in jan 2019.All the incoming raw materials, in-process quality assurance inspection and final inspections have been completed.As per investigation, in-process quality assurance (ipqa) and pre-shipment quality assurance (psqa) have performed the buy off inspection process and passed within the specification limits based on the random sampling plan.No deviation was raised on the incoming, in-process or final stages of the product.

one open inner of sample returned for investigation.The sample was sent out to an external lab for testing.The primary skin irritation test shows that there was no observable irreversible alteration on the skin at the sites of contact with the test material.The chemical residues test results shows that no detection of the chemicals residues that could cause an allergic reaction.

there were no changes in the process, production, machine, and raw materials used during the manufacturing process.Additionally, the gloves have been tested through dermal sensitization test and primary skin irritation test.However, there were not any abnormalities observed during the test performed.

the operating parameters were within the validation range.The pre-leaching and post-leaching reading for all ripping machine involved were well within the specification.The pre-shipment inspection results indicated that the product under the lot number has met the specified requirement per product specification and release criteria before released for shipment.From the investigation, the root cause could not be determined.We will continue monitoring customer complaints for trends, which may require further investigation.

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Manufacturer Narrative

The sample was received by cardinal health plant on 9/24/2020.The sample was forwarded to the glove supplier and was sent out to an external lab for testing.The testing can take up to 3 months.A follow-up will be sent once testing evaluation is received back to cardinal health.

• Brand Name: GLV EXAM NITRILE FLEXAL COMFORT MD
• Type of Device: PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): SGP01 SINGAPORE; 10 kallang avenue , #10-10/18; singapore 33951 0; SN 339510
• MDR Report Key: 10502763
• MDR Text Key: 205965846
• Report Number: 1423537-2020-00510
• Device Sequence Number: 1
• Product Code: FMC
• UDI-Device Identifier: 20885380166317
• UDI-Public: 20885380166317
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 88FS03M
• Device Catalogue Number: 88FS03M
• Device Lot Number: 12P19A031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 68