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

Catalog Number J-PF-POST

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Pain (1994); Burning Sensation (2146); Hot Flashes/Flushes (2153); Urinary Frequency (2275); Anxiety (2328); Arthralgia (2355); Depression (2361); Inadequate Pain Relief (2388); Sweating (2444); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 08/18/2011

Event Type  Injury  

Manufacturer Narrative

Surgeon name not provided by the complainant.Implant date not provided by the complainant.*the device is no longer marketed in the us or ous as the device is no longer manufactured.* *this mdr is related to (b)(4).* a review of the device lot history record indicated the device was manufactured to specifications.The non-conformance would not have contributed to the reported occurrence.Four devices were produced from the lot.A review of the cbi complaint database did not reveal any additional 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 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 reported injury remain unknown.A root cause of the reported injury is inconclusive due to the lack of details provided by the complainant.

Event Description

(b)(4).A patient reported directly to the tga that she had an operation for a prolapse of womb.Since having the device fitted, the patient reports suffering with constant pain down her legs, pelvic area, buttocks, back, hips, and vagina, aching joints, and hot flushes.The patient also reported that her memory is affected as is her ability to walk, sit, sleep, and drive.The patient's anxiety and depression have increased as has her skin conditions.She can no longer have sexual intercourse due to pain.The patient also reported having constant tiredness, lack of energy, struggles to do everyday tasks, and needs to urinate frequently.She has a burning sensation in her feet and sweating and feeling hot all the time.

• Brand Name: BIODESIGN POSTERIOR PELVIC FLOOR GRAFT
• Type of Device: PELVIC FLOOR POSTERIOR
• 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: 7408064
• MDR Text Key: 104734282
• Report Number: 1835959-2018-00007
• Device Sequence Number: 1
• Product Code: PAI
• UDI-Device Identifier: 10827002482279
• UDI-Public: (01)10827002482279(17)130131(10)LB510190
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: J-PF-POST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2018
• Date Device Manufactured: 07/01/2011
• 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