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Model Number 416740 |
Device Problems
Malposition of Device (2616); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Device 1 of 2.Contact office address: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
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Event Description
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This emdr is for an unknown quantity of affected wafers from the same lot.The end user's daughter reported that the end user received shipment of pouches where the pre-cut hole was off centered and misshaped in 7 market units with the same lot number.The daughter stated some were worse than others, ones she tried to wear had reduced wear time and some she changed 3 or 4 times in a day, but others were just so far off she couldn't get the pouch to work if she had tried those, so she threw those away.The end user's daughter did not have any specific numbers for what was worn and what was discarded.No photo is available at this time.
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Manufacturer Narrative
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(b)(6).Batch record review results: lot 0m00978 was manufactured on 12/10/2020 in the cvx1pc manufacturing line, with a total of (b)(4) mkus.On 19/aug/2021, a batch record review was performed to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom.No issues related to the defect were found in the documentation.On 19/aug/2021 a complaint search for lot 0m00978 and malfunction code ost-pmc1.8 / ost-pmc01.08 skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only) was carried out and as a result, no additional complaints were found; therefore, no potential trend is observed.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.
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Event Description
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To date no additional patient or event details have been received.
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Search Alerts/Recalls
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