Model Number 31140208 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Submit date: 06/13/2016.An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove.The customer states that the product is breaking.
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Manufacturer Narrative
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Submit date: 10/19/2016.The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One case of samples with original packaging was received and the reported issue was not confirmed; none of the samples presents the reported condition.A corrective and preventative action (capa) has been opened to determine the root cause of this reported event.When root cause(s) is determined the appropriate actions will be taken to address the reported condition.If additional information is received this complaint will be reopened.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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