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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Seroma (2069); Hernia (2240)
Event Date 06/01/2012
Event Type  Injury  
Event Description
Limited information was reported through a legal event that on (b)(6) 2011 a (b)(6) female underwent a procedure to treat hernia reoccurrence and adhesions. During the procedure, strattice was implanted. Lysis of adhesions and bilateral component separation was performed. On (b)(6) 2012 a second revision surgery was performed and strattice was explanted. Fat necrosis was noted and excised over the mesh and seroma was noted. In 2019 the patient underwent additional surgeries for hernia repair. No other information was reported.
 
Manufacturer Narrative
The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed. No strattice devices were returned for evaluation. Based on the limited information reported, a relationship between the event and strattice could not be determined. Due to the legal process, if additional information is made available during legal proceedings, the information will be sent to product surveillance for further evaluation. To date, no additional information has been received. No further actions are required, a nonconformance was not confirmed.
 
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Brand NameUNKNOWN STRATTICE
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key14435306
MDR Text Key292025587
Report Number1000306051-2022-00098
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 Other,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2022
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
Date Manufacturer Received04/22/2022
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: 05/19/2022 Patient Sequence Number: 1
Treatment
NO INFORMATION REPORTED
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