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Catalog Number 0115311 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Fever (1858); Unspecified Infection (1930); Weakness (2145)
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Event Date 01/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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As reported, the patient experienced infection post implant of 3dmax mesh, underwent surgery intervention for mesh explant.Based on the information provided to date, no conclusion can be made as to the degree to which the device, may have caused or contributed the patient¿s reported postoperative course.Infection is a known inherent risk of surgery.The warnings section of the instructions-for-use supplied with the device states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." a review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of 662 units released for distribution in june, 2019.This mdr represents the bard/davol 3dmax implanted on the patient¿s left side (device #1).An additional mdr was submitted to represent the bard/davol 3dmax implanted on the patient¿s right side (device #2).Should additional information be provided, a supplemental mdr will be submitted.
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Event Description
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It was reported that during a laparoscopic procedure on (b)(6) 2020, the patient underwent bilateral implant of two bard/davol 3dmax meshes.It was reported that on (b)(6) 2020, post-implant, patient started having fever, weakness and infection, which was confirmed with mri and sonography.As reported, on (b)(6) 2021, both mesh devices were explanted through a laparoscopic procedure.It was also reported that patient is currently on iv antibiotic piptaz (piperacillin tazobactum).
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Search Alerts/Recalls
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