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Catalog Number 1016002 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Hernia (2240)
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Event Type
Injury
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Manufacturer Narrative
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This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore a review into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, and without relevant patient factors, a relationship between the event and the strattice could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
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Event Description
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Limited information was reported through a legal event that a patient was implanted with strattice on (b)(6) 2013.The form also indicates that on an unspecified date, the strattice implant had been ¿removed or revised¿.No information was provided on the indication for the initial surgery or the reason for the removal or revision.
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Manufacturer Narrative
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Additional and/or corrected data: a2, a3, b5, d1, d4, h4, h6 a review of the device history record for strattice lot s11170 has been initiated.If any new, changed or corrected information is noted, a supplemental report will be submitted.This is a known potential adverse event addressed in the product labeling.A relationship between the strattice and this event could not be conclusively determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
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Event Description
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On 17/jan/2024, pmqa received notification from legal that the plaintiff profile form was received associated with this event.As per the ppf form, the patient underwent a ¿ventral hernia¿ surgery and was implanted with strattice device on (b)(6) 2017.The patient underwent an ¿exploratory laparotomy with extensive lysis of adhesions and primary abdominal wall closure with mesh onlay¿ on (b)(6) 2015.As per the ppf form, the patient claims the implantation and failure of the mesh caused ¿pain, recurrence, adhesions, perforated component separation, emotional injuries with and without treatment, and intervention surgery.¿ the form lists the conditions that were treated were ¿pain, recurrence, adhesions, perforated component separation, and intervention surgery¿ with approximate date of treatment of (b)(6) 2015.The ppf form also indicates the patient was implanted with a non-abbvie device, "ethicon prolene,¿ on (b)(6) 2015.The form indicates that this device was not removed or revised.
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Search Alerts/Recalls
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