Model Number 37449 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device 15 of 18.(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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It was reported by the product distributor that "the adhesive does not stick properly".Upon clarification it was reported that "the part that sticks to the skin, loosens up and falls off after a few hours".There was no harm reported by end users.No photograph depicting the reported compliant issue submitted by the complainant.
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Manufacturer Narrative
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Correction (g1) - (b)(6) as a result of our investigation two main causes were detected: 1.Sealing issue ¿ poor seal between flaps and foam due to incorrect sealing settings on the production line which was caused by broken adjustment knob.Corrective actions were defined and implemented in capa: (b)(4).2.Adhesion issue ¿ no issues found during manufacturing process of 1772 3m foam used for defective batches.No other complaints reported.Detailed analysis cannot be performed due to fact, that samples were not received.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092.Manufacturing site:1049092.
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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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