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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE MESH, SURGICAL

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LIFECELL UNKNOWN STRATTICE MESH, SURGICAL Back to Search Results
Catalog Number UNK STRATTICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
This mdr is being reported as an individual event type for serious injury. Multiple attempts were made to contact the corresponding author for additional information, including relevant lot numbers. To date, no additional information has been obtained. The device was not returned for evaluation and the lot number remains unknown; therefore, internal investigation into the event could not be performed. Based on the reported information, a relationship between the event and strattice cannot be determined. If additional information is reported, a follow up adverse event report will be submitted. No further actions are required as a nonconformance could not be confirmed.
 
Event Description
Journal article "utility of a modified components separation for abdominal wall reconstruction in the liver and kidney transplant population" discusses incisional hernia is a common complication following visceral organ transplantation. Transplant patients are at increased risk of primary and recurrent hernias due to chronic immune suppression and large incisions. We conducted a retrospective review of patients with a history of liver or kidney transplantation who underwent hernia repair to analyze outcomes and hernia recurrence. This is a single center, retrospective review of 19 patients who received kidney and/or liver transplantation prior to presenting with an incisional hernia from 2011 to 2017. All hernias were repaired with open component separation technique (cst) with biologic mesh underlay. The mean age of patients was 61. 0±8. 3 years old, with a mean body mass index of 28. 4±4. 8 kg/m2, 15 males (78. 9%), and four females (21. 1%). There were seven kidney, 11 liver, and one combined liver and kidney transplant patients. The most common comorbidities were hypertension (16 patients, 84. 2%), diabetes (9 patients, 47. 4%), and tobacco use (8 patients, 42. 1%). Complications occurred in six patients (31. 6%) including hematoma (1/19), abscess (1/19), seroma (2/19), and hernia recurrence (3/19) at mean follow-up of 28. 7±22. 8 months. With the exception of two patients with incomplete follow-up, all patients healed at a median time of 27 days. This small, retrospective series of complex open cst in transplant patients shows acceptable rates of long-term hernia recurrence and healing. By using a multidisciplinary approach for abdominal wall reconstruction, we believe that modified open cst with biologic mesh is a safe and effective technique in the transplant population with complex abdominal hernias.
 
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Brand NameUNKNOWN STRATTICE
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer (Section G)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
6014545899
MDR Report Key9454741
MDR Text Key170938876
Report Number1000306051-2019-00132
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK STRATTICE
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 Received11/12/2019
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: 12/11/2019 Patient Sequence Number: 1
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