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Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Local Reaction (2035)
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Event Type
malfunction
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Manufacturer Narrative
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This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).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.D4: catalog number is unknown.D4: udi information is unknown.G5: premarket (510k) number is unknown.
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Event Description
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It was reported that the device was causing pruritus in the patient.No medical or surgical intervention was reported.
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Manufacturer Narrative
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Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Correction : b1: product problem, corrected data: corrected data : b1: product problem.
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Search Alerts/Recalls
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