MAUDE Adverse Event Report: COOK BIOTECH SURGISIS; NONE

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 07/06/2010

Event Type  Injury  

Event Description

The pt was reportedly implanted with an unspecified surgisis graft on (b)(6) 2008.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 corrective surgery.A review of medical records indicated that on (b)(6) 2008, the pt underwent a repair of rectocele with surgisis graft, performed by cesar santiago, md at southwest florida regional medical center, for the treatment of her high rectocele from vaginal delivery injury.A 2x4 piece of surgisis graft was placed along the rectovaginal septum.The graft was used in a bridging fashion.On (b)(6) 2010, the pt was seen by (b)(6), md at (b)(6) ctr.Dr (b)(6) indicated the pt had perineal scarring postpartum.Another surgeon felt uncomfortable repairing the area.A transverse perineoplasty was previously performed by a colorectal surgeon.The pt noted no improvement in her vaginal laxity after that surgery.The pt continued to have dyspareunia.No significant prolapse was noted, perineal scarring was present, and there was marked introital laxity.There was a small moderate rectocele.Recommendation was for rectocele repair and vertical perineoplasty, but there was concern that the pt may still have dyspareunia.On (b)(6) 2010, dr (b)(6) noted the pt had dyspareunia secondary to scarring and marked laxity.On (b)(6) 2010, the pt underwent a rectocele repair and perineoplasty, performed by (b)(6), md at (b)(6) ctr, for the treatment of her symptomatic rectocele and dyspareunia.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

Product name not known due to product unspecified by the complainant.Product common name not known due to product unspecified by the complainant.Lot number not provided by the complainant.Product expire date unk as lot number not provided by the complainant.Product catalog number unk as product unspecified by complainant.The 510(k) unk as product was unspecified 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.Product manufacture date unk as lot number not provided by the complainant.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, 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 appears the pt had a recurrence of her rectocele for which the unspecified surgisis graft was placed to repair.It does not appear that the unspecified surgisis 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 unspecified surgisis graft being placed that should they recur would be likely to cause or contribute to death, serious injury, or require medical or surgical intervention to preclude serious injury or death.A root cause of the pt's rectocele recurrence is inconclusive.Many factors may have contributed to the pt's rectocele repair, such as the bridging fashion in which the graft was placed, the pt's underlying condition and history, and the pt's post-operative activity.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 file.

Manufacturer Narrative

Date of event not provided by the complainant.Product name unknown; product unspecified.Product common name unknown; product unspecified - product code pag / pai.Lot number not provided by the complainant.Product expire date unknown; lot number not provided.Product catalog number unknown, product unspecified.The 510(k) unknown; product unspecified.As requested by the fda, we have made note of the product code.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.Update: the root cause of the recurrent rectocele remains unchanged from the previous evaluation.The root cause, of the patient¿s current complaints, is inconclusive and unlikely directly related to the implantation of the surgisis graft.

Event Description

The patient was reportedly implanted with an unspecified surgisis graft on (b)(6) 2008.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 corrective surgery.A review of medical records indicated that on (b)(6) 2008, the patient underwent a repair of rectocele with surgisis graft, performed by cesar santiago, md at southwest florida regional medical center, for the treatment of her high rectocele from vaginal delivery injury.A 2 x 4 piece of surgisis graft was placed along the rectovaginal septum.The graft was used in a bridging fashion.On (b)(6) 2010, the patient was seen by (b)(6), md at (b)(6) health center.Dr.(b)(6) indicated the patient had perineal scarring postpartum.Another surgeon felt uncomfortable repairing the area.A transverse perineoplasty was previously performed by a colorectal surgeon.The patient noted no improvement in her vaginal laxity after that surgery.The patient continued to have dyspareunia.No significant prolapse was noted, perineal scarring was present, and there was marked introital laxity.There was a small moderate rectocele.Recommendation was for rectocele repair and vertical perineoplasty, but there was concern that the patient may still have dyspareunia.On (b)(6) 2010, dr.(b)(6) noted the patient had dyspareunia secondary to scarring and marked laxity.On (b)(6) 2010, the patient underwent a rectocele repair and perineoplasty, performed by (b)(6), md at lee memorial health center, for the treatment of her symptomatic rectocele and dyspareunia.Update: the patient reported that the rectocele has again recurred.

• Brand Name: SURGISIS
• Type of Device: NONE
• 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 Key: 3682996
• MDR Text Key: 19921663
• Report Number: 1835959-2014-00008
• Device Sequence Number: 1
• Product Code: PAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 01/14/2016

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: UNKNOWN
• 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
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• 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
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 33 YR