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Catalog Number ARTY |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.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.Was the outer box which holds the foil pouch sealed? was the product missing? was the device/packaging returned for analysis?.
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Event Description
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It was reported that the patient underwent an sacrocolpopexy procedure on unknown date and the mesh was implanted.During the procedure, when the exterior package of the mesh was opened, the nurse found that the interior package of the product was opened already.Additional information has been requested.
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Manufacturer Narrative
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One actual sample was received showing the box packaging, the foil with folder and mesh inside.The foil presented an open side at the flaps with handling appearance of foil opening.After mesh dispense out of the folder the mesh itself shows no defects.No degradation was observed.The box packaging was opened at the perforated side.Both security stickers are still present and intact.
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Search Alerts/Recalls
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