MAUDE Adverse Event Report: SGP01 SINGAPORE GLV EXAM NITRILE FLEXAL FEEL PF SM; PATIENT EXAMINATION GLOVE

Model Number 88TT21S

Device Problem Device Emits Odor (1425)

Patient Problems Skin Discoloration (2074); Swelling (2091); Reaction (2414)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

The device history record for the lot number reported (11k19j007) was reviewed to identify any issues during the glove manufacturing process ¿ no abnormal conditions were identified.Compounding was carried in accordance with approved requirements and no additional amount of chemical was added during the manufacturing process.No changes been made to the manufacturing process, product formulation and raw materials used.Our supplier treated the raw water and performed tests on the water in the frequency of every 4 hours, 8 hours and daily basis to monitor the treated water quality.They had reviewed and checked the raw water treatment process parameters and test results.They confirmed that the water quality is within specification.The ph test had been conducted on both the complaint lots and control lot to determine the ph-value of the gloves.The results show that the complaint and control gloves ph are within specification.Particulate residual test conducted on both the complaint lots and control lot as per specification.5 pcs of retained sample gloves from each complaint lots and control lot were evaluated.The results show that the particulate residual were within specification.Bio-burden level on glove had been tested on the retained samples for both complaint lots and control lot.The results show that it is within specification.Ftir test performed on the retained sample for the complaint lots and control lot for both the external and internal sides of the gloves.The ftir spectrum trend for both complaint lots and control lot looked similar.There is no difference or abnormality showed on the complaint lots.Safety of the final glove had been accessed.The test concluded that the gloves were non irritant and non sensitizing.We will continue to monitor trends and utilize the information as part of continuous improvement.

Event Description

Customer reported a box of exam gloves appeared to contain a strong chemical odor, and that several employees were having skin reactions after using them.Reportedly, one employee experienced symptoms of discoloration, resembling early stage blistering, but no formation of blisters.All involved supervisors were notified of the concern, and advised to have their staff inspect all gloves prior to use, and take any suspected contaminated gloves out of service.The strongest odor has been identified as the flexal feel glove, but the odor is noticeable among all sizes at a lesser degree.

Manufacturer Narrative

The physical sample was received on (b)(6) 2019.The supplier sent the physical sample to an outside facility for testing.When the test results are provided, a follow-up report will be filed.

Manufacturer Narrative

A review of the device history record for lot number: 11k19j007, revealed the manufacturing process parameters were within the specification.Compounding was carried out in accordance with approved bill of materials(bom) and no additional amount of chemical were added during the manufacturing process.No changes were made to the manufacturing process, product formulation and raw materials used.Internally, the supplier treated the raw water and performed tests on the water in the frequency of every 4 hours, 8 hours and daily basis to monitor the treated water quality.The testing performed include turbidity, ph, true color, total soluble solid(tss), iron, manganese, aluminium, free chlorine, ammonia and total coliform tests.They had reviewed and checked the raw water treatment process parameters and test results.They confirmed that the water quality is within specification and complying with ministry of health(moh) drinking water standards and food regulation 1985 requirement.Ph test had been conducted on both the complaint lots and control lot to determine the ph-value of the gloves.The results show that the complaint and control gloves ph are within specification.Particulate residual test conducted on both the complaint lot (retained and returned sample) and control lot as per procedure.Five pieces of retained sample gloves from each complaint lots and control lot were evaluated.The results show that the particulate residual were within specification.Bioburden level on glove had been tested on the retained and returned sample of complaint lot and control lot.The results show that it is within specification.Ftir test performed on the retained and returned sample of complaint lots and control lot for both the external and internal sides of the gloves.The ftir spectrum trend for both retained and returned samples of complaint lots and control lot looked similar.There is no difference or abnormality showed on the complaint lots.The supplier had sent both retained and returned samples of affected lot to rubber research institute (rri) for chemical extraction test.We had received the testing result for both retained and returned samples of the affected lot.The chemical extraction test results showed that there was no excess concentration of chemical detected on both retained and returned samples.It proves that their compounding was carried out in accordance with their approved bom and gloves were manufactured according to the validated parameters.Safety of the final glove had been accessed.The gloves had been sent for animal irritation test and dermal sensitization assay test.The test concluded that the gloves were non irritant and non sensitizing.Based on the investigation results, the root cause could not be determined.

• Brand Name: GLV EXAM NITRILE FLEXAL FEEL PF SM
• 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: 9390482
• MDR Text Key: 168862585
• Report Number: 1423537-2019-00375
• Device Sequence Number: 1
• Product Code: FMC
• UDI-Device Identifier: 10885380135910
• UDI-Public: 10885380135910
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 88TT21S
• Device Catalogue Number: 88TT21S
• Device Lot Number: 11K19J007
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/28/2019
• Supplement Dates Manufacturer Received: 10/31/2019; 10/31/2019
• Supplement Dates FDA Received: 12/29/2019; 01/29/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 95