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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN STRATTICE MESH, SURGICAL

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UNKNOWN STRATTICE MESH, SURGICAL Back to Search Results
Catalog Number UNK STRATTICE
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Bacterial Infection (1735); Capsular Contracture (1761)
Event Type  Injury  
Manufacturer Narrative
This mdr is being reported as a multiple events type for serious injury with an abundance of caution. There is no confirmation of the possible relationship the strattice. The corresponding author has not provided additional clinical information. The device was not returned for evaluation and the lot numbers remain 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
The impact of premastectomy versus postmastectomy radiation therapy on outcomes in prepectoral implant-based breast reconstruction author catherine sinnott, general surgeon a literature publication from a retrospective chart review in the u. S. On the use of strattice in prepectoral implant-based breast reconstruction. Strattice was used in all 592 reconstructions. The purpose of the study was to compare complication rates for patients who received pre-mastectomy radiation treatment to patients who received post-mastectomy radiation treatment to patients who received no radiation treatment. The conclusion determined that in prepectoral implant breast reconstruction, premastectomy and postmastectomy radiation therapy were associated with higher rates of infection and implant loss compared with nonradiated patients. Postmastectomy radiation was associated with a higher rate of capsular contracture compared with nonradiated. Article is attached.
 
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Brand NameUNKNOWN STRATTICE
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key12058132
MDR Text Key258426906
Report Number1000306051-2021-03020
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 literature
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
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 Received05/26/2021
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: 06/24/2021 Patient Sequence Number: 1
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