MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-10-25 for BIODESIGN POSTERIOR PELVIC FLOOR GRAFT J-PF-POST manufactured by Cook Biotech.
[58300991]
Product common name posterior pelvic floor graft; product code pag. This mdr is related to mdr 1835959-2016-00627. The lot number lb591263c, as noted by the complainant, was narrowed down to lb591263. Lb591263 is a valid cbi lot number. Device history records can be found in the attached files. The shipping records indicate that one device of lb591263 was shipped to (b)(4) on 12/11/2012. A review of the cbi complaint database did not reveal any previously reported complaints that match the details of this feedback. 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 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 allegations is inconclusive due to the lack of details provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[58300992]
(b)(4). This was documented as device incident report (b)(4). The patient reported she was implanted with two surgisis biodesign posterior pelvic floor grafts. One graft was placed in the anterior vaginal compartment and the other graft was placed in the posterior vaginal compartment. The date of implantation, surgical procedure performed, facility in which the surgery took place and the surgeon's name were not provided by the complainant. The patient reported experiencing continuous post-operative pain and a general feeling of being unwell. She also reported a discharge of blood and an offensive smell. The pain was described as sharp and stringing throughout the pelvic region. The patient also reported having persistent infections followed by skin changes, a loss of balance, and general malaise with the pain throughout the first twelve months after surgery. She indicated that the pain still persists, at the present time, and that the systems for which the procedure was performed to correct are worse than before surgery. The patient reports having permanent incontinence of both bowel and bladder and a foul smelling pelvic discharge (putrid seroma). She indicated she has had a loss of quality of life and is unable to have sexual intercourse. The patient reports that the products are unable to be removed and have caused irreparable internal damage.
Patient Sequence No: 1, Text Type: D, B5
[73362830]
Product common name posterior pelvic floor graft; product code pag. Implant date reported as (b)(6) 2012. This mdr is related to mdr 1835959-2016-00627. The lot number lb591263c, as noted by the complainant, was narrowed down to lb591263. Lot# lb591263 is a valid cbi lot number. Device history records can be found in the \files. The shipping records indicate that one device of lb591263 was shipped to the (b)(6) hospital in (b)(6) on 12/11/2012. A review of the cbi complaint database did not reveal any previously reported complaints that match the details of this feedback. 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 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 allegations is inconclusive due to the lack of details provided by the complainant. Update: the additional details received do not alter the previous investigation summary.
Patient Sequence No: 1, Text Type: N, H10
[73362831]
(b)(4). 2 x grafts were implanted in both anterior ((b)(4)) & posterior((b)(4)) compartments of vagina. Pain in the vaginal region was continuous, general feeling unwell persisted continually after surgery. Having pain and continuously, discharge of blood tissue and offensive smell. Sharp, stringing pain throughout pelvic region. Persistent infections followed by skin changes and loss of balance, general malaise continuing with pain intensity throughout first 12 months continually - till present time. All of the systems which the operation was performed to correct are now worse than ever. Permanent incontinence from both bowel & urethra. Persistent pain associated with new formation of number of adhesions, product has integrated, with natural tissue causing all pelvic tissue to become necrotic causing continuous pelvis discharge with foul smell (putrid seroma). Loss of quality of life, unable to have sexual intercourse. Product is unable to be removed and has caused irreparable damage internally. Update: new information received which revealed the patient's identity, age at the time of biodesign surgisis posterior pelvic floor graft(s) implant, surgeon's name, geographical location implant took place, and date of implant. In (b)(6) 2012, the patient underwent surgery performed by dr. (b)(6) , for repair of minor incontinence and pelvic prolapse issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1835959-2016-00626 |
| MDR Report Key | 6053428 |
| Report Source | CONSUMER |
| Date Received | 2016-10-25 |
| Date of Report | 2017-04-04 |
| Date Mfgr Received | 2017-03-22 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2016-10-25 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIODESIGN POSTERIOR PELVIC FLOOR GRAFT |
| Product Code | PAG |
| Date Received | 2016-10-25 |
| Catalog Number | J-PF-POST |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-10-25 |