MAUDE Adverse Event Report: COOK BIOTECH, INC. BIODESIGN VAGINAL EROSION REPAIR GRAFT

Catalog Number J-ERG-6

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 a surgisis vaginal erosion repair graft on (b)(6) 2011, by dr.(b)(6), at (b)(6) care health system in (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.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 patient status.

Manufacturer Narrative

Date of event not provided by the complainant.Lot number not provided by the complainant.Product expire date unknown; lot number not provided.Product catalog number unknown, product unspecified.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.Product manufacture date unknown; lot number unknown.Conclusions: root cause inconclusive due to lack of details provided by the complainant.This mdr is related to mdr 1835959-2014-00052.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 surgisis vaginal erosion repair graft's performance and the alleged injury remain unknown.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, a follow-up mdr will be filed.

• Brand Name: BIODESIGN VAGINAL EROSION REPAIR GRAFT
• Type of Device: VAGINAL EROSION REPAIR GRAFT
• Manufacturer (Section D): COOK BIOTECH, INC.; west lafayette IN 47906
• Manufacturer Contact: perry guinn, vp ; 1425 innovation place; west lafayette, IN 47906
• MDR Report Key: 3800434
• MDR Text Key: 4385645
• Report Number: 1835959-2014-00058
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992159
• 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: 04/03/2014

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: Health Professional
• Device Catalogue Number: J-ERG-6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 04/03/2014
• 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: NONE REPORTED BY THE COMPLAINANT
• Patient Outcome(s): Disability