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Model Number 21-7230-24 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Nodule (4551)
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Event Date 03/05/2020 |
Event Type
malfunction
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Event Description
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It was reported that, with use of the device, an inflammatory nodule appeared in the abdomen when the insertion device was removed after the infusion was administered.No medical or surgical intervention was reported.
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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 for evaluation; however, a review of the manufacturing process was performed.No discrepancies were detected during visual inspection.No discrepancies were found during the inspection test.No root cause could be determined since the complaint could not be confirmed since no samples or pictures were received for evaluation.Operator of device is patient/consumer this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.
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Search Alerts/Recalls
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