(b)(4).
Corrected information: narrative - it was reported by the patient that he underwent a left inguinal hernia repair on (b)(6) 2011 and mesh was used.
Within a month of the procedure, the patient experienced pain.
Several months after the surgery it was noted that there was a hole in the incision and the patient had an infection.
The patient contacted his physician who prescribed antibiotics for the infection.
During 2012 the patient had a second procedure to remove the mesh.
The patient reports the mesh had become wrapped around blood vessels and nerves.
He required a partial vasectomy to restore blood flow to his left testicle.
No further information is available.
In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
This medwatch report is in response to receipt of maude event report mw (b)(4).
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It was reported that the patient underwent a left inguinal hernia repair and mesh was implanted on (b)(6) 2011.
It was reported that post operatively he experienced pain, redness, oozing and infection at the site of the surgery.
He was rx antibiotics in (b)(6) 2011 for the ¿open wound.
¿ on (b)(6) 2012, he underwent surgery to remove the mesh, and it was found that the mesh was deteriorated, wrapped around nerves, which required a neurectomy and partial vasectomy to restore blood flow to his left testicle.
He continues to experience burning pain in abdomen, genitals, thigh and hip and unable to engage in sexual relations.
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