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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK BIOTECH, INC. UNK - UNSPECIFIED BY THE COMPLAINANT; UNK - PRODUCT UNSPECIFIED
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COOK BIOTECH, INC. UNK - UNSPECIFIED BY THE COMPLAINANT; UNK - PRODUCT UNSPECIFIED Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Injury (2348)
Event Type  Injury  
Event Description
The patient was reportedly implanted with an ethicon tvt-exact and a bard avaulta solo posterior synthetic support system on (b)(6) 2011 by dr.(b)(6) and a sis graft on (b)(6) 2013 by dr (b)(6).Both surgeries took place at (b)(6).The patient and her atty have alleged that as a result of these products being implanted in the patient, the patient has experienced pain, injury, and has undergone med treatment.The following info was not provided by the complainant: specific info of the alleged injury, specific info regarding whether intervention was performed, specific info regarding why interventions was performed or what type / to what extent intervention was performed, specific correlation between device performance and alleged injury, current patient status.
 
Manufacturer Narrative
Conclusion: root cause inconclusive due to lack of details provided by the complainant.Investigation into this claim included a review of the claim allegations and all other communication and investigation into this report/claim is being handled by our atty.Based on the info provided by the complainant, details regarding a specific correlation between the unspecified sis graft's performance and the alleged injury remains 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 atty.If / when additional info is obtained a follow up mdr will be filed.
 
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Brand Name
UNK - UNSPECIFIED BY THE COMPLAINANT
Type of Device
UNK - PRODUCT UNSPECIFIED
Manufacturer (Section D)
COOK BIOTECH, INC.
west lafayette IN 47906
Manufacturer Contact
perry guinn, vp, qa, ra
1425 innovation place
west lafayette, IN 47906-1000
7654973355
MDR Report Key4101711
MDR Text Key20129982
Report Number1835959-2014-00931
Device Sequence Number1
Product Code PAG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
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 08/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/08/2014
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
IMPLANTED:; ETHICON TVT-EXACT; SYSTEM; BARD AVAULTA SOLO POSTERIOR SYNTHETIC SUPPORT; IMPLANTED:
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