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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK BIOTECH UNKNOWN
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COOK BIOTECH UNKNOWN Back to Search Results
Catalog Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
Concomitant product: boston scientific the obtryx transobturator mid-urethral sling system: (b)(6) 2010.The product code listed is not necessarily the product code assigned to the device 510(k), but rather the product code that seems the most appropriate based on the surgical procedure in which the product was implanted.
 
Event Description
The patient was reportedly implanted with a boston scientific the obtryx transobturator mid-urethral sling system on (b)(6) 2010 at (b)(6) surgical center, (b)(6) by dr.(b)(6).The patient was also reportedly implanted with a cook stratasis on (b)(6) 2013 at (b)(6) by dr.(b)(6).The patient and her attorney have alleged that as a result of these products being implanted in the patient, the patient has experienced pain, injury, and has undergone medical treatment.
 
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Brand Name
UNKNOWN
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 Key5285172
MDR Text Key33243109
Report Number1835959-2015-00259
Device Sequence Number1
Product Code PAG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 12/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/24/2015
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
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