MAUDE Adverse Event Report: COOK BIOTECH, INC. BIODESIGN 4-LAYER TISSUE GRAFT; SURGISIS ES

Catalog Number C-SLH-4S-7X10

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

On (b)(6) 2006, the pt underwent a cystocele repair with surgisis es soft tissue graft and an autologous fascia pubovaginal sling procedure, performed by (b)(6), md at (b)(6), for the treatment of her cystocele and stress urinary incontinence.The pt and her attorney have alleged that as a result of this product being implanted in the pt, the pt has experienced pain and injury.On (b)(6) 2007, the pt underwent a cystoscopy and pelvic exam, performed by (b)(6), md, for eval of urinary incontinence status post pubovaginal sling.The impression was that the pt likely had urge incontinence that had developed in novo since the procedure.On (b)(6) 2007, the pt underwent cystoscopy and video urodynamic study for eval of persistent small volume incontinence.The cystoscopy and urodynamics did not elicit a cause for the pt's incontinence.There was no apparent recurrent cystocele.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 intervention was performed or what type/to what extent intervention was performed; specific correlation between device performance and alleged injury; current pt status.

Manufacturer Narrative

Date of event not provided by the complainant.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.No testing methods performed as product not returned to cbi.Conclusion: root cause inconclusive.Investigation eval: investigation into this claim included a review of the claim allegations; a review of the cbi complaint system; a review of the device history records which indicated the product was mfg to specs; a review of the surgisis es soft tissue graft ifu fp0005-1h, and all other communication and investigation into this report/claim is being handled by our attorney.Summary of investigation findings: after reviewing the details received, it does not appear that the surgisis es soft tissue graft caused or contributed to any life threatening illness or injury, permanent impairment or damage, nor did the pt require medical or surgical intervention to preclude serious injury or death as a result of the graft being placed.The pt did not experience any symptoms as a result of the surgisis es soft tissue graft being placed that should they recur would be likely to cause or contribute to death, serious injury, require medical or surgical intervention to preclude serious injury or death.Based on the info provided by the complainant, details regarding a specific correlation between the surgisis es soft tissue graft's performance and the alleged injury remain unk.A root cause of the claim allegations is inconclusive.It appears the surgisis es soft tissue graft performed as the surgeon intended in repairing the pt's cystocele.All other matters relating to this litigation are being handled by our attorney.If/when add'l info is obtained, a f/u mdr will be filed.

• Brand Name: BIODESIGN 4-LAYER TISSUE GRAFT
• Type of Device: SURGISIS ES
• 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: 3683001
• MDR Text Key: 17567393
• Report Number: 1835959-2014-00006
• Device Sequence Number: 1
• Product Code: PAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/24/2014

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 Expiration Date: 01/31/2008
• Device Catalogue Number: C-SLH-4S-7X10
• Device Lot Number: LB294079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2014
• Initial Date FDA Received: 02/24/2014
• 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