(b)(6).Product code pag / pai.As requested by the fda, we have made note of the product code.The product code listed is not necessarily the product code assigned to the device 510(k), but rather the product code that seems the most appropriate based on the surgical procedure in which the product was implanted.Based on the information provided by the complainant, details regarding a specific correlation between a cook biotech incorporated manufactured product¿s performance and the alleged injury remain unknown.A root cause of the claim allegations is inconclusive due to the lack of details provided by the complainant.All other matters relating to this litigation are being handled by our attorney.A follow-up mdr will be filed if additional details are received.
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The patient was reportedly implanted with an unspecified manufacturer's pelvic mesh product(s).The patient and her attorney have alleged that as a result of this/these product(s) being implanted in the patient, the patient has experienced pain, injury, and has undergone medical treatment.
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