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Model Number 31201 |
Device Problems
Migration or Expulsion of Device (1395); Material Deformation (2976)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Hernia (2240)
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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.This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant.This report shall not be considered as an admission by atrium medical that the product described in the lawsuit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the plaintiff.
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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 pain, adhesions, mesh contracture, mesh migration, lack of mesh incorporation and re-herniation.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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Manufacturer Narrative
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Additional information: age/date of birth, describe event or problem, other relevant history, model #/lot #, device manufacture date and evaluation codes.Investigation: 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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Event Description
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Plaintiff allegedly also experienced incarceration, fibrosis, foreign body giant cell reaction and abdominal pain.
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Search Alerts/Recalls
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