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Catalog Number 0616002 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hernia (2240)
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Event Date 07/06/2017 |
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 an internal investigation into the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information, including no identification of the lot number, 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) 2012.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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Event Description
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This is follow up#1 to report on 25/jan/2024, mqa received notification from legal that the plaintiff profile form was received associated with this event.As per the ppf form, the patient underwent an ¿incarcerated ventral hernia¿ surgery and was implanted with strattice device lot: s11072-123 on (b)(6) 2012.The patient underwent a ¿recurrent incisional hernia repair with mesh¿ on (b)(6) 2017.As per the ppf form, the patient claims the implantation and failure of the mesh caused ¿pain, recurrence, and intervention surgery.¿ the form lists the conditions that were treated were ¿pain, recurrence, and intervention surgery¿ with approximate date of treatment on (b)(6) 2017.The ppf form also indicates the patient was implanted with a non-abbvie device, " ethicon / j&j physiomesh; lot#: ophy1215¿ on (b)(6) 2017.The form indicates that this device has not been removed or revised.As reported in the initial: limited information was reported through a legal event that a patient was implanted with strattice on (b)(6) 2012.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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This legal event is being reported as serious injury due to the reported recurrence with surgical intervention.A review of the device history record for strattice lot: s11072 has been initiated.If any new, changed or corrected information is noted, a supplemental report will be submitted.No strattice devices were returned for evaluation.This is a known potential adverse event addressed in the product labeling.Without relevant patient factors, a relationship between the strattice and this event could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.Additional, changed, and/or corrected data.
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Search Alerts/Recalls
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