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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN 4-LAYER TISSUE GRAFT SURGISIS ES

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COOK BIOTECH BIODESIGN 4-LAYER TISSUE GRAFT SURGISIS ES Back to Search Results
Catalog Number J-SLH-4S-7X10
Device Problems Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)
Patient Problems Hair Loss (1877); Pain (1994); Swelling (2091); Ulcer (2274); Injury (2348); Ambulation Difficulties (2544); Blood Loss (2597); Abdominal Distention (2601)
Event Type  Injury  
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 manufacture date unknown; lot number unknown. This mdr is related to mdr 1835959-2018-00003 and (b)(6). A direct root cause, of the incident described in (b)(6), is inconclusive due to a lack of details. The implant date was noted as (b)(6) 2011. It is important to note that the surgisis biodesign tissue graft is biologic in nature and is resorbed and replaced with natural tissue in a few months post-implantation, leaving nothing behind. In fact, our product was often used to repair the failure of synthetic meshes. Although a direct root cause is inconclusive, the patient¿s reported long term effects are not likely related to the use of the surgisis biodesign tissue graft due to the resorbtion properties of the device. Many factors could contribute to the patient¿s reported outcome including, but not limited to, surgical technique, positioning of the patient while on the operating table, underlying patient conditions, and the patient¿s post-operative care activities.
 
Event Description
Per (b)(6): the patient reportedly was implanted with a surgisis biodesign tissue graft on (b)(6) 2010 and (b)(6) 2011, by dr. (b)(6) at (b)(6) hospital / (b)(6) hospital. Over a period of six years, since the device implants, the patient reported experiencing increasingly severe debilitating pain to the pelvic area and bowel which extends to the hip, back and leg. The patient also reported being unable to walk unaided and only for few a meters. Walking any further distance requires the use of a wheelchair due to the severe constant pain. The pain was described as feeling like broken glass in the pelvic area and sporadic stabbing pain to groin resulting in leg giving away. Lastly, the patient reported inability to have sex as it is too painful, swelling to lower limbs, pronounced swelling to abdomen, recurrent mouth ulcers, loss of blood to tip of finger, loss of hair, and brittle, flaking nails.
 
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Brand NameBIODESIGN 4-LAYER TISSUE GRAFT
Type of DeviceSURGISIS ES
Manufacturer (Section D)
COOK BIOTECH
1425 innovation place
west lafayette IN 47906
Manufacturer (Section G)
COOK BIOTECH INCORPORATED
1425 innovation place
west lafayette IN 47906
Manufacturer Contact
perry guinn
1425 innovation place
west lafayette, IN 47906
7654973355
MDR Report Key7321345
MDR Text Key101840774
Report Number1835959-2018-00004
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K980431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other Caregivers
Type of Report Initial,Followup
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberJ-SLH-4S-7X10
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
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 Treatment Data
Date Received: 03/07/2018 Patient Sequence Number: 1
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