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Catalog Number 4007 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/21/2020 |
Event Type
malfunction
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Event Description
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It was reported that when the pouch was opened, it was confirmed the film had been creased, so it was not used for treatment.A backup was available.No delay was reported.The sample will not be returned because it was discarded, and no photo is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing record did not identify any issue at the point of manufacture which may have caused or contributed to the issues highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaint history review was carried out using the lot and part number provided, there have been further complaints reported with this failure mode in the past three years.The device was used for treatment and creasing was found on the film.As no samples were returned for analysis, a potential cause for this problem is a raw material issue.There are checks in place to prevent creasing of the film.If creasing is identified during in-process checks, it is tabbed and recorded in the fault log.On this occasion the operator appears to have missed the issue.Minor creasing can sometimes occur in the film during the adhesive application process at the start or end of the roll.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause on this occasion.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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Search Alerts/Recalls
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