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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 Cellulitis (1768); Fistula (1862); Seroma (2069)
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. The device remains implanted. 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
It was reported that a female patient underwent a reduction mammoplasty and was excessively reduced. (date of surgery was not provided). In a follow up procedure, the patient underwent a breast implant procedure to increase volume. She also had three or four breast augmentation revisions including an initial revision in the summer of 2017 using strattice bilaterally to reinforce lateral capsulorrhaphy. The patient did well but received a steroid injection in her back sometime in (b)(6) 2017. (no indication was provided). Subsequently, the patient started thinning at her lateral breast soft tissue. In (b)(6) 2018, the patient developed cellulitis and seroma which responded to clindamycin. A breast implant migrated cephalad and then returned to normal position. In (b)(6) 2018, the patient developed recurrent seroma, cellulitis, and had spontaneous drainage of the seroma. She now has a small fistula tract.
 
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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 Key7441755
MDR Text Key105882316
Report Number1000306051-2018-00050
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 04/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
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 Received03/22/2018
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: 04/18/2018 Patient Sequence Number: 1
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