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

Catalog Number J-PF-ANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Date of event not provided by the complainant.Product common name - anterior pelvic floor graft; product code pag.A review of the device history records indicated the device was manufactured to specifications.Two devices were produced from the lot.A review of the cbi complaint database did not reveal any previously reported complaints involving the reported lot number.The ifu notes that the following complications are possible with the use of surgical graft materials: bleeding, infection, adhesions, sterile effusion, chronic inflammation, allergic reaction, and delayed or failed incorporation of the device.If conditions of infection, inflammation, or allergic reaction cannot be resolved, consider removal of the graft.Based on the information provided by the complainant, details regarding a specific correlation between the surgisis biodesign anterior pelvic floor grafts 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 surgisis biodesign anterior pelvic floor graft on (b)(6) 2010, at (b)(6) hospital in (b)(6) , by dr.(b)(6).The patient and her attorney have alleged that as a result of this product being implanted in the patient, the patient has experienced pain, injury, and has undergone medical treatment.

• Brand Name: BIODESIGN ANTERIOR 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: 6105609
• MDR Text Key: 59989519
• Report Number: 1835959-2016-00631
• Device Sequence Number: 1
• Product Code: PAI
• UDI-Device Identifier: 10827002466057
• UDI-Public: (01)10827002466057(17)110630(10)LB439585
• 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: 11/14/2016

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: J-PF-ANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/16/2016
• Date Device Manufactured: 01/01/2010
• 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