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 Type
malfunction
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Manufacturer Narrative
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Device 6 of 14.(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 that "the device slowly detach from the skin and a new one needs to be placed." the device was reported in use on the "patient's neck, previously there was always more time adhered (time not informed), now it is necessary to change the device every day, as there is no adherence".It was further reported ¿according to the patient¿s speech, there was no displacement of the patient's gastrostomy tube.No harm reported.No photographs depicting the reported complaint issue was received by the complainant.
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Manufacturer Narrative
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Correction (g1) - contact office address: (b)(4).An investigation was performed and retain batches were checked.The results of the investigation showed 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.2) adhesion issue ¿ no issues found during manufacturing process for defective batches.No other complaints reported.A detailed analysis cannot be performed because no samples were received for inspection.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.Third party manufacturing site: 2183581.
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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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