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Model Number 31505 |
Device Problems
Migration or Expulsion of Device (1395); Retraction Problem (1536); Material Deformation (2976)
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Patient Problems
Adhesion(s) (1695); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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We are unable to fully investigate this event as no product code, lot number, or sample was provided.Not returned.
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Event Description
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This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical¿s mesh product plaintiff allegedly experienced wrinkle, migrated and retracted mesh, and additional surgery.Since this is a legal matter, the case has been turned over to legal counsel and further information obtained through investigation or discovery may fall under the attorney/client and/or work product privilege.However, atrium will supplement this report as appropriate if additional information comes to its attention.
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Event Description
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N/a.
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Manufacturer Narrative
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Correction section: a3 additional information a2.
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Event Description
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Plaintiff also allegedly experienced recurrence, incarceration, diastasis recti and adhesions.
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Manufacturer Narrative
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Correction section: a2.Additional information section: b5, b7, d4, h4, h6.Based on the review of the device history records and product complaint details atrium can find no fault with the product.This lot of mesh passed all quality and performance requirements.
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Search Alerts/Recalls
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