MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2019-03-22 for UNKNOWN manufactured by Cook Biotech.
[139546398]
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.
Patient Sequence No: 1, Text Type: N, H10
[139546400]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1835959-2019-00001 |
| MDR Report Key | 8443265 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-19 |
| Date of Event | 2009-09-03 |
| Date Mfgr Received | 2019-03-18 |
| Date Added to Maude | 2019-03-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PERRY GUINN |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal | 47906 |
| Manufacturer Phone | 7654973355 |
| Manufacturer G1 | COOK BIOTECH INCORPORATED |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Product Code | PAG |
| Date Received | 2019-03-22 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK BIOTECH |
| Manufacturer Address | 1425 INNOVATION PLACE WEST LAFAYETTE IN 47906 US 47906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-03-22 |