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

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.

• 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 Key: 4203291
• MDR Text Key: 18543218
• Report Number: 1835959-2014-00970
• Device Sequence Number: 1
• Product Code: PAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974540
• Number of Events Reported: 1
• 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 Number: N/A
• Device Catalogue Number: C-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 Received: 10/23/2014
• 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 Number: 1
• Treatment: ETHICON TVT-0 810081, LOT 2980713; ETHICON PROLIFT TOTAL PFRT01 LOT 2987234
• Patient Outcome(s): Disability