Product complaint # (b)(4).The following information has been requested with no response to date: photo of reaction? date of procedure? did the patient have a confirmed infection? were any tests performed? if yes, provide details and results? patient symptoms manifestations (location, severity, appearance, systemic or local reaction)? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra-operation? please describe how was the adhesive was applied on the tape what prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? attempts have been made to retrieve the device.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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Product complaint # (b)(4).Sent to the fda: 10/23/2019.H3 evaluation: the analysis results found that two clr222 devices were returned inside its package unopened.As per evaluation results, it was observed that the returned device was received unopened and no defects were detected related with the packaging.The samples were opened, and all the components were noted to be as expected.Functional test was performed and no issues were observed.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the samples received, no problems were found, and the tested samples met the finished goods requirements.
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