MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN 4-LAYER TISSUE GRAFT; SURGISIS ES

Catalog Number UNKNOWN

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Concomitant products - ams elevate on (b)(6) 2011; coloplast restorelle on (b)(6) 2013.Based on the information provided by the complainant, details regarding a specific correlation between the biodesign or surgisis 4-layer tissue graft'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 obtained.

Event Description

The patient was reportedly implanted with an american medical systems elevate on (b)(6) 2011, at (b)(6).Additionally, the patient was reportedly implanted with a biodesign or surgisis 4-layer tissue graft on (b)(6) 2012, at (b)(6).Finally, the patient was reportedly implanted with a coloplast restorelle on (b)(6) 2013, at (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.

• Brand Name: BIODESIGN 4-LAYER TISSUE GRAFT
• Type of Device: SURGISIS ES
• Manufacturer (Section D): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• Manufacturer Contact: perry guinn ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 5516384
• MDR Text Key: 40930257
• Report Number: 1835959-2016-00029
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980431
• 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: 03/22/2016

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 03/22/2016
• 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
• Patient Outcome(s): Disability