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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE SURGICAL MESH

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LIFECELL CORPORATION STRATTICE SURGICAL MESH Back to Search Results
Model Number UNKNOWN
Device Problem Contamination (1120)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Based on the reported information and without an associated lot number, a relationship between the event and the strattice cannot be conclusively determined. Lifecell reports this event in an abundance of caution. Should additional clinical and product specific information be retrieved, an updated mdr will be submitted. Device not returned for evaluation.
 
Event Description
Limited information was reported to lifecell that a patient originally had a synthetic mesh (non-lifecell product) removed and replaced with strattice. The patient became infected and the doctor treated the area with antibiotics. The patient was also scheduled to be returned to the operating room for removal of the strattice because the area is infected again (specific dates, products, and clinical details were not provided).
 
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Brand NameSTRATTICE
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
LIFECELL CORPORATION
one millennium way
branchburg NJ 08876
Manufacturer Contact
christopher belle
one millennium way
branchburg, NJ 08876
9089471470
MDR Report Key6618114
MDR Text Key76852191
Report Number1000306051-2017-00029
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
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 06/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberN/A
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 Received05/09/2017
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: 06/07/2017 Patient Sequence Number: 1
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