MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN 8-LAYER TISSUE GRAFT; SYMPHASIS

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

The pt was reportedly implanted with a biodesign or surgisis 8-layer tissue graft on (b)(6) 2005, at (b)(6) hospital in (b)(6), by dr (b)(6).The pt and her attorney have alleged that as a result of this product being implanted in the pt, the pt has experienced pain, injury, and has undergone medical 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 intervention was performed or what type / to what extent intervention was performed; specific correlation between device performance and alleged injury; current pt status.

Manufacturer Narrative

Date of event not provided by the complainants.Lot number not provided by the complainant; product expire date unknown; lot number not provided; product catalog number unknown; product unspecified.Product manufacture date unknown; lot number unknown.Conclusions: root cause inconclusive due to lack of details provided by the complainant.Investigation into this claim has 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 info provided by the complainant, details regarding a specific correlation between the biodesign or surgisis 8-layer tissue graft's performance and the alleged injury remain unknown.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 attorney.If/when additional info is obtained a follow-up mdr will be filed.

• Brand Name: BIODESIGN 8-LAYER TISSUE GRAFT
• Type of Device: SYMPHASIS
• Manufacturer (Section D): COOK BIOTECH; west lafayette IN 47906
• Manufacturer Contact: perry guinn, vp ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 4539231
• MDR Text Key: 5537798
• Report Number: 1835959-2015-00039
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2015
• 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: NONE REPORTED BY THE COMPLAINANT
• Patient Outcome(s): Disability