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Model Number 66034 |
Device Problem
Gel Leak (1267)
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Patient Problems
Discomfort (2330); Skin Inflammation/ Irritation (4545)
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Event Date 11/22/2021 |
Event Type
malfunction
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Event Description
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The customer reported that the polymer beads were outside the fluff layer of the brief, coming in contact with the skin and causing discomfort and irritation for the patients.
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Manufacturer Narrative
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The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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Manufacturer Narrative
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The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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Event Description
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The customer reported that the polymer beads were outside the fluff layer of the brief, coming in contact with the skin and causing discomfort and irritation for the patients.
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Manufacturer Narrative
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A device history record could not be complete as the lot number provided by the customer is invalid for the reported product code.A product analysis was unable to be completed as to date no samples or pictures have been provided.Precluding any further information or evidence there is not enough information at this time to determine with any confidence what likely caused the reported issue; therefore, the root cause is undetermined.Based on the information available and the investigation findings, a risk assessment was conducted, and management personnel was made aware of the complaint details.The reported condition could not confirm a manufacturing deficiency.If additional information is received warranting further analysis, the investigation may be resumed.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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