(b)(6).Date of event not provided by the complainant.Product name unknown; manufacturer unspecified; product unspecified - product code pag / pai.Product common name unknown; manufacturer unspecified; product unspecified.Lot number not provided by the complainant.Product expire date unknown; lot number not provided.Product catalog number unknown, product unspecified.Surgeon name not provided by the complainant.Implant date not provided by the complainant.The 510(k) unknown; product unspecified.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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