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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK BIOTECH INC BIODESIGN HIATAL HERNIA GRAFT

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COOK BIOTECH INC BIODESIGN HIATAL HERNIA GRAFT Back to Search Results
Model Number N/A
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Injury (2348)
Event Type  Injury  
Event Description
The pt was reportedly implanted with an ethicon prolift, an ethicon tvt-o, and a surgisis es on or about (b)(6) 2007 and (b)(6) 2007 at (b)(6).The pt and her attorney have alleged that as a result of this product being implanted in the pt, the pt has experienced pain, injury and has undergone medical treatment.The following information was not provided by the complainant: specific information of the alleged injury, specific information regarding whether intervention was performed, specific information regarding why intervention was performed or what type / to what extent intervention was performed, specific correlation between device performance and alleged injury, current pt status.The complainant indicated the cook biotech inc (cbi) manufactured product to be a "surgisis es, product code c-phr-7x10-u; lot l8272278." a c-phr-7x10-u graft is not labeled as a surgisis es.Also, the lot l8272278 is not a valid cbi lot number.However, lb272278, is a valid cbi lot number that does not coincide with a surgisis es, a c-phr-7x10-u, nor was that lot shipped to mobile infirmary in (b)(4), as indicated by the complainant.Additionally, the complainant listed 3 products and two implant dates, but did not indicate which products were implanted on which specific date.As such, for purposes of filing this mdr, the complaint will be filed under a c-phr-7x10-u device.The implant date remains unclear and will be updated when any additional information provides clarity.
 
Manufacturer Narrative
Root cause inconclusive due to lack of details provided by the complainant.Investigation into this claim has included a review of the claim allegations and all other communication and investigation into this report/claim is being handled by our attorney.Based on the information provided by the complainant, details regarding a specific correlation between the hiatal hernia graft's performance and the alleged injury remain unk.A root cause of the claim allegations is inconclusive due to lack of details provided by the complainant.All other matters relating to this litigation are being handled by our attorney.If/when additional information is obtained, that alters our conclusion to this complaint, a follow-up mdr will be filed.
 
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Brand Name
BIODESIGN HIATAL HERNIA GRAFT
Type of Device
HIATAL HERNIA GRAFT
Manufacturer (Section D)
COOK BIOTECH INC
west lafayette IN 47906
Manufacturer Contact
perry guinn, vp
1425 innovation place
west lafayette, IN 47906
7654973355
MDR Report Key4203291
MDR Text Key18543218
Report Number1835959-2014-00970
Device Sequence Number1
Product Code PAI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974540
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 10/23/2014
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 Other
Device Model NumberN/A
Device Catalogue NumberC-PHR-7X10-U
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/17/2014
Initial Date FDA Received10/23/2014
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 Number1
Treatment
ETHICON TVT-0 810081, LOT 2980713; ETHICON PROLIFT TOTAL PFRT01 LOT 2987234
Patient Outcome(s) Disability;
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