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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 Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Manufacturer Narrative
Conclusion: based on limited information, including no identification of the relevant lot number, a relationship between the event and strattice could not be determined. Due to lack of information, strattice as a contributing factor cannot be ruled out. Lifecell reports the event in an abundance of caution. Multiple attempts to obtain additional information are being made, including identification of the lot number. Should additional information be reported, a follow up adverse event report will be submitted; otherwise this investigation is concluded.
 
Event Description
This report is associated with the left-side strattice mesh. Please refer to mdr 1000306051-2018-00041 for the right-side strattice mesh report. It was reported that a (b)(6) year old female patient had previously undergone bilateral mastectomy, tissue expander, and implant reconstructions. On (b)(6) 2018, the patient was returned to surgery for partial capsulectomy, revision, and repair. Intraoperatively, the left side showed poor ingrowth of strattice and required removal and replacement of the breast implant. The revision was completed and the patient was taken to recovery in good condition.
 
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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
9089471100
MDR Report Key7343312
MDR Text Key102580044
Report Number1000306051-2018-00042
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 03/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
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 Received02/14/2018
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: 03/15/2018 Patient Sequence Number: 1
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