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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

The patient was reportedly implanted with a biodesign or surgisis anterior pelvic floor graft, a biodesign or surgisis 4-layer tissue graft, a biodesign or surgisis 8-layer tissue graft, an ams in-fast on (b)(6) 2008, and an ams in-fast on (b)(6) 2009.The complainant noted surgery dates of (b)(6) 2006, (b)(6) 2008 (maybe a typo as (b)(6) 2008 is specified for one of the ams in-fast), (b)(6) 2009.The complainant did not specify which biodesign product was implanted on which specific date.The surgeries were performed at (b)(6) hosp.In (b)(6) and were performed by dr.(b)(6).The patient and her attorney have alleged that as a result of these products being implanted in the patient, the patient has experienced pain, injury, and has 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

(b)(4).Product manufacture date unk, lot number unk.Conclusions code: root cause inconclusive due to lack of details provided by the complainant.This mdr is related to mdr 1835959-2015-00085 and mdr 1835959-2015-00086.Investigation - evaluation; 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 attorney.Summary of investigation findings: based on the information 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 for the complainant.All other matters relating to this litigation are being handled by our attorney.If/when additional information 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: 4790523
• MDR Text Key: 5877626
• Report Number: 1835959-2015-00087
• 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: 05/20/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2015
• Initial Date FDA Received: 05/20/2015
• 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: AMS IN-FAST; BIODESIGN OR SURGISIS 4-LAYER TISSUE GRAFT; AMS IN-FAST; BIODESIGN OR SURGISIS ANTERIOR PELVIC FLOOR GRAFT
• Patient Outcome(s): Disability