MAUDE Adverse Event Report: COOK BIOTECH UNKNOWN

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Pain (1994)

Event Date 09/03/2009

Event Type  Injury  

Manufacturer Narrative

Product name unknown; product unspecified.Product common name unknown; product unspecified.Product code pag / pai.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.Lot number not provided by the complainant.Product expire date unknown; lot number not provided.Product catalog number unknown, product unspecified.Surgeon name not provided by the complainant.Implant date not provided by the complainant.Occupation: non-healthcare professional.510(k) unknown; product unspecified.Product manufacture date unknown; lot number not provided.Related to tga dir 56388 - artg # 153049; reported to tga by patient.Based on the information provided by the patient, details regarding a specific correlation between the unspecified porcine collagen graft's performance and the alleged injury remain unknown.A root cause of the patient's allegations is inconclusive due to the lack of details provided.A follow-up mdr will be filed if additional details are obtained.

Event Description

The patient reported directly to tga that she underwent an anterior and posterior vaginal repair bolstered with a third generation remodeling porcine collagen biograft fixed into place with bilateral sacrospinous colpopexies.A trans obturator tape, tvt, (american medical systems-monarc) was inserted as a cure of stress procedure.The porcine collagen graft utilised was a cook medical product which was harvested from the small intestine sub mucosa of the domestic pig.This is an acellular three dimensional collagen graft rich in signaling proteins and growth factors which supposedly remodels over 3 - 6 months into native tissue.No porcine product is supposed to be detectable after 6 months.Unfortunately this graft has potentially not remodeled into native tissue and further research indicates that it allegedly remains in the body and causes similar complications experienced by women who have been implanted with polypropylene devices.After experiencing chronic pelvic pain, joint pain and ongoing health issues for many years with numerous referrals to specialists and tests the patient was referred to dr.(names and date were not supplied by reporter [tga]) performed full removal the american medical systems monarch tvt and dr performed a posterior vaginal repair, laparoscopic suture hysteropexy, division of adhesions and cystoscopy.After initial surgery recovery period, the patient's condition did improve slightly.Even though she was fully incontinent from bladder and bowels, she was not experiencing the doubling over abdominal pain, but, the pain in her hips, general pelvic area, lower back and coccyx persisted and gradually worsened.She has sought specialist option all over the eastern states of (b)(6) and has not been able to resolve the ongoing chronic pain.She has lost her job with the public service and has had to claim a permanent invalidity pension from her superannuation and disability support pension.She had to declare bankruptcy due to not being able to keep up her repayments on a small debt and is unable to socialise.She was a single mother of 4 sons and had experienced 20 years of domestic violence.She had started a new life and was supporting he family.She had been dealing with stress incontinence since the birth of her first child at the age of 19.She had not taken the decision lightly to have this surgery and was advised that it would change her life.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• Manufacturer (Section G): COOK BIOTECH INCORPORATED; 1425 innovation place; west lafayette IN 47906
• Manufacturer Contact: perry guinn ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 8443265
• MDR Text Key: 139546398
• Report Number: 1835959-2019-00001
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: AMS MONARCH TVT
• Patient Outcome(s): Disability