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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 Hematoma (1884); Necrosis (1971); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
Ref. Initial reporter: corresponding author and associated institution. This mdr is being reported as an individual event type for serious injury due to the medical and surgical intervention to treat the superficial infections, necrosis and hematoma. As reported in the article, there were no septic incidents or readmissions for intravenous antibiotic treatment. It was not specified if any of the strattice devices were removed for the necrosis or hematoma complications. Lifecell has made multiple attempts for additional information, including relevant lot numbers. To date no additional information has been received. The lot numbers associated with these events remain unknown; therefore an internal investigation could not be performed. Based on the reported information, a relationship between the events and the strattice devices cannot be determined. If additional information is received, a follow up report will be filed.
 
Event Description
During a device alert literature review, an article titled "prophylactic nipple-sparing mastectomy and direct-to-implant reconstruction of the large and ptotic breast: is preshaping of the challenging breast a key to success?" was identified which reported a study of patients with large, ptotic breasts requesting a prophylactic mastectomy with immediate breast reconstruction from december of 2013 to december of 2015 that were offered a two-stage procedure: a preshaping mastopexy/reduction followed by a delayed nipple-sparing mastectomy/direct-to implant reconstruction. Within the study period, the two-stage procedure was performed in 22 women with large, ptotic breasts who opted for a bilateral risk-reducing mastectomy and immediate breast reconstruction. The median age of the patients was 46 years (range, 26 to 62 years). Known risk factors and comorbidities, diabetes and hypertension, and smoking habits were registered. An 8 x 16 cm sheet of strattice was used. The primary outcome measure was the number of partial and total nipple necroses and registered all complications encountered and the long-term result of achieved or failed reconstruction. Two patients had reoperations under general anesthesia, one because of hematoma and one because of fat necrosis. Five patients had minor complications, two with small wound dehiscence and three with superficial infection/redness treated with antibiotics. All red breasts were treated with antibiotics regardless of other signs, and there were no septic incidents or readmissions for intravenous antibiotic treatment.
 
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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 Key7494187
MDR Text Key107586849
Report Number1000306051-2018-00064
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
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 Received04/09/2018
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: 05/08/2018 Patient Sequence Number: 1
Treatment
NO INFORMATION
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