BIODESIGN ANTERIOR PELVIC FLOOR GRAFT J-PF-ANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-11-16 for BIODESIGN ANTERIOR PELVIC FLOOR GRAFT J-PF-ANT manufactured by Cook Biotech.

Event Text Entries

[59989519] Date of event not provided by the complainant. Product common name - anterior pelvic floor graft; product code pag. A review of the device history records indicated the device was manufactured to specifications. Two 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. 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 the device. 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 surgisis biodesign anterior pelvic floor grafts 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.
Patient Sequence No: 1, Text Type: N, H10


[59989520] The patient was reportedly implanted with a surgisis biodesign anterior pelvic floor graft on (b)(6) 2010, at (b)(6) hospital in (b)(6) , by dr. (b)(6). The patient and her attorney have alleged that as a result of this product being implanted in the patient, the patient has experienced pain, injury, and has undergone medical treatment.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1835959-2016-00631
MDR Report Key6105609
Report SourceCONSUMER
Date Received2016-11-16
Date of Report2016-11-14
Date Mfgr Received2016-11-03
Device Manufacturer Date2010-01-01
Date Added to Maude2016-11-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. PERRY GUINN
Manufacturer Street1425 INNOVATION PLACE
Manufacturer CityWEST LAFAYETTE IN 47906
Manufacturer CountryUS
Manufacturer Postal47906
Manufacturer Phone7654973355
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIODESIGN ANTERIOR PELVIC FLOOR GRAFT
Product CodePAI
Date Received2016-11-16
Catalog NumberJ-PF-ANT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOOK BIOTECH
Manufacturer Address1425 INNOVATION PLACE WEST LAFAYETTE IN 47906 US 47906


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2016-11-16

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