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

Catalog Number J-PF-POST

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Product common name - posterior pelvic floor graft; product code - pag.A review of the device history records indicated the device was manufactured to specifications.A total of five 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.A review of the ifu revealed ¿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 graft.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 biodesign 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 bard align and a biodesign surgisis posterior pelvic floor graft on (b)(6) 2011, at (b)(6), 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.

• 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: 6110788
• MDR Text Key: 60288076
• Report Number: 1835959-2016-00630
• Device Sequence Number: 1
• Product Code: PAG
• UDI-Device Identifier: 10827002482279
• UDI-Public: (01)10827002482279(17)120229(10)LB471320
• 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-POST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/17/2016
• Date Device Manufactured: 10/01/2010
• 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: BARD ALIGN
• Patient Outcome(s): Disability