Catalog Number W1611T |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? when did the needle pull off (while in the package / during dispensing / during preparation / during use)? batch number ljt840 is invalid.Please provide the correct batch number.
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Event Description
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It was reported that a patient underwent a plastic surgery procedure on (b)(6) 2018 and suture was used.When using the suture, the suture detached from the needle.No patient consequences were reported.Additional information has been requested.
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Manufacturer Narrative
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Product complaint # (b)(4).Additional information was requested and the following was obtained: 1.Did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? there's no piece fell inside patient.2.When did the needle pull off (while in the package / during dispensing / during preparation / during use)? the needle is pull off during the preparation.3.Batch number (b)(4) is invalid.Please provide the correct batch number the batch number can't be provided at the moment despite the follow up.The customer discarded the product.
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Search Alerts/Recalls
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