MAUDE Adverse Event Report: COOK BIOTECH, INC. UNK - UNSPECIFIED BY COMPLAINANT; UNK - PRODUCT UNSPECIFIED

Catalog Number UNSPECIFIED

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

The pt was reportedly implanted with a boston scientific advantage fit system and a surgis tissue graft both on (b)(6) 2008 and (b)(6) 2014.The surgeries took place at (b)(6) and were performed by dr (b)(6).The pt and her atty have alleged that as a result of these products being implanted in the pt, the pt has experienced pain, injury, and has undergone med treatment.The following info was not provided by the complainant: specific info of the alleged injury, specific info regarding whether intervention was performed, specific info regarding why interventions was performed or what type / to what extent intervention was performed, specific correlation between device performance and alleged injury, current patient status.

Manufacturer Narrative

Conclusion: root cause inconclusive due to lack of details provided by the complainant.This mdr is related to mdr 1835959-2014-00926 and is for product 1 of 2.Investigation into this claim included a review of the claim allegations and all other communication and investigation into this report/claim is being handled by our atty.Based on the info provided by the complainant, details regarding a specific correlation between the unspecified surgisis tissue graft's performance and the alleged injury remains unk.A root cause of the claim allegations is inconclusive due to lack of details provided by the complainant.All other matters relating to this litigation are being handled by our atty.If / when additional info is obtained a follow up mdr will be filed.

• Brand Name: UNK - UNSPECIFIED BY COMPLAINANT
• Type of Device: UNK - PRODUCT UNSPECIFIED
• Manufacturer (Section D): COOK BIOTECH, INC.; west lafayette IN 47906
• Manufacturer Contact: perry guinn, vp, qa/ra ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 4101705
• MDR Text Key: 4840349
• Report Number: 1835959-2014-00925
• 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
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNSPECIFIED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2014
• Initial Date FDA Received: 08/28/2014
• 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: IMPLANTED:; BOSTON SCIENTIFIC ADVANTAGE FIT SYSTEM; BOSTON SCIENTIFIC ADVANTAGE FIT SYSTEM; IMPLANTED:
• Patient Outcome(s): Disability