MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN POSTERIOR PELVIC FLOOR GRAFT

Catalog Number UNKNOWN

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Concomitant products - biodesign or surgisis tension free urethral sling on (b)(6) 2013; biodesign or surgisis anterior pelvic floor graft on (b)(6) 2013.The 510(k) unknown; product unspecified.The product code 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.This mdr is related to mdr 1835959-2016-00048 and mdr 1835959-2016-00049.Based on the information provided by the complainant, details regarding a specific correlation between the biodesign or surgisis posterior pelvic floor 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 a biodesign or surgisis tension-free urethral sling, a biodesign or surgisis anterior pelvic floor graft, and a biodesign or surgisis posterior pelvic floor graft at (b)(6) hospital in (b)(4), by dr.(b)(6).The complainant noted implant dates of (b)(6) 2013, but did not indicate which product(s) was implanted on which date.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 POSTERIOR PELVIC FLOOR GRAFT
• 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: 5568238
• MDR Text Key: 42414061
• Report Number: 1835959-2016-00050
• Device Sequence Number: 1
• Product Code: PAI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/11/2016

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: 04/08/2016
• Initial Date FDA Received: 04/11/2016
• 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