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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN ANTERIOR PELVIC FLOOR GRAFT

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COOK BIOTECH BIODESIGN ANTERIOR PELVIC FLOOR GRAFT Back to Search Results
Catalog Number J-PF-ANT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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.
 
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Brand Name
BIODESIGN ANTERIOR PELVIC FLOOR GRAFT
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 Key6105609
MDR Text Key59989519
Report Number1835959-2016-00631
Device Sequence Number1
Product Code PAI
UDI-Device Identifier10827002466057
UDI-Public(01)10827002466057(17)110630(10)LB439585
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992159
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 11/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberJ-PF-ANT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/03/2016
Initial Date FDA Received11/16/2016
Date Device Manufactured01/01/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NONE REPORTED BY THE COMPLAINANT.
Patient Outcome(s) Disability;
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