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Model Number 21-7230-24 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Bruise/Contusion (1754)
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Event Date 01/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No corrective actions are required since the complaint could not be confirmed since no samples or pictures were received for evaluation.Operator of device is patient/consumer.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
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Event Description
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It was reported that the patient had faint yellowed bruise a size of cannula pad (two centimeters) at two insertion sites, faint yellowed bruising at the infusion site right of navel size cannula pad and faint yellowed bruise, left of navel, size of cannula pad at insertion site.No medical or surgical intervention was reported.
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Search Alerts/Recalls
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