Catalog Number SURGICAL UNKNOWN |
Device Problem
Deflation Problem (1149)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that during use, the catheter balloon would not deflate.At the time of this report, the customer has not returned our requests for additional information.
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Manufacturer Narrative
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(b)(4).New information received indicates that this was not a reportable event, thus, the initial mdr submitted on 24 april 2024 should be retracted.
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Event Description
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It was reported that during use, the catheter balloon would not deflate.At the time of this report, the customer has not returned our requests for additional information.
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Search Alerts/Recalls
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