Catalog Number CLR602 |
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 03/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts to obtain the following information has been performed but not received.If the further details are received at a later date a supplemental medwatch will be sent were there any adverse consequences to the patient? was medical or surgical intervention, or anesthesia required when reapplying prineo? is the product involved in the event or a representative sample (product from the same lot number) available for evaluation? to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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Event Description
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It was reported a patient underwent a circumferential abdominoplasty surgery on (b)(6) 2020 and surgical sealant was used.Post operative day 3, it was necessary to remove the tape and apply another one as it was coming off.Surgeon needed to reapply mesh and adhesive.No patient consequences reported.Additional information was requested.
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Manufacturer Narrative
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Product complaint # (b)(4).Date sent to the fda: 513/2020.Attempts to obtain the following information has been performed and the following was received.If the further details are received at a later date a supplemental medwatch will be sent were there any adverse consequences to the patient? was medical or surgical intervention, or anesthesia required when reapplying prineo? is the product involved in the event or a representative sample (product from the same lot number) available for evaluation? all the information we have about complaint provided.No more to add.
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Search Alerts/Recalls
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