MAUDE Adverse Event Report: COOK BIOTECH, INC. UNKNOWN - UNSPECIFIED BY THE COMPLAINANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

The patient was reportedly implanted with an unspecified manufacturer's pelvic mesh product(s).On (b)(6) 2010.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 undergone medical treatment.The following information was not provided by the complainant: specific information of the alleged injury, specific information regarding whether intervention was performed, specific information regarding why intervention was performed or what type/to what extent intervention was performed, specific correlation between device performance and alleged injury, current patient status.

Manufacturer Narrative

Date of event not provided by the complainant.Product name unknown; product unspecified.Product common name unknown; 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.The product 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.Product manufacture date unknown; lot number unknown.Method - actual device not evaluated.Results - no results available since no evaluation performed.Conclusions , root cause inconclusive due to lack of details provided by the complainant.Investigation in to this claim included a review of the claim allegations and all other communication and investigation into this report/claim is being handled by our attorney.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 allegations is inconclusive due to lack of details provided by the complainant.All other matters relating this litigation are being handled by the attorney.If/when additional information is obtained a follow up mdr will be filed.

• Brand Name: UNKNOWN - UNSPECIFIED BY THE COMPLAINANT
• Type of Device: UNKNOWN - UNSPECIFIED
• Manufacturer (Section D): COOK BIOTECH, INC.; west lafayette IN 47906 100
• Manufacturer Contact: perry quinn, vp., qa/ra ; 1425 innovation place; west lafayette, IN 47906-1000 ; 7654973355
• MDR Report Key: 4375538
• MDR Text Key: 5260549
• Report Number: 1835959-2014-00683
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED BY THE COMPLAINANT