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Catalog Number 1161015 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); Constipation (3274)
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Event Date 05/15/2020 |
Event Type
Injury
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Manufacturer Narrative
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As reported, the patient with a history of prior abdominal surgeries underwent implant of the bard/davol xenmatrix graft and is experiencing pain, tightness and bowel issues for which he is being treated with pain medication.The patient has undergone two mri, with no findings.At this time it is unknown what is causing the patient¿s reported postoperative symptoms.Based on the information provided, no conclusion can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event is provided as a best estimate based on the reported symptoms four months of post implant.Should additional information be provided, a supplemental mdr will be submitted.Not returned - remains implanted.
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Event Description
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As reported, the patient had a number of abdominal surgeries and needed the abdominal rectus muscles reattached and repaired on the left side.As reported, the patient underwent a bilateral reinforcement with implant of an unspecified bard/davol xenmatrix graft on (b)(6) 2020, which was used as an overlay and sutured at the left pubic bone along the inguinal and external oblique and rectus muscles.It was reported that about 4 months post op, the patient started to experience significant pain and tightness, as described ¿feels like a squeezing of his bowels, significant stretching from his rib cage to his pubic bone.¿ as reported, the patient had difficulty with bowels and took multiple laxatives; the patient reached out to the surgeon who performed the surgery who ordered an mri on two separate occasions with no findings.As reported, the patient had a prescription for narcotics but chose to take otc pain medication as the narcotic pain medication causes constipation and did not want to cause any more issues with his bowels.It was also reported that the patient continues to feel a significant stretching in abdomen with associated pain.
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Search Alerts/Recalls
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