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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 Problem Hernia (2240)
Event Date 04/03/2013
Event Type  Injury  
Manufacturer Narrative
This legal event is being reported as serious injury due to the reported recurrence with surgical intervention. 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 cannot be confirmed. Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
 
Event Description
It was reported through a legal event that a (b)(6) year old female patient had hernia repair surgery on or about (b)(6) 2012. During the hernia repair surgery, the surgeon implanted a strattice firm mesh. The patient had a revision surgery on (b)(6) 2013, during which an additional strattice mesh was implanted. After these surgeries, the patient returned to the hospital for a revision surgery on (b)(6) 2014, during which strattice mesh was explanted. This record is associated with the strattice device implanted on (b)(6) 2012.
 
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Brand NameUNKNOWN STRATTICE
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key13843989
MDR Text Key287575815
Report Number1000306051-2022-00038
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
Type of Report Initial
Report Date 03/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2022
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 Received02/25/2022
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: 03/21/2022 Patient Sequence Number: 1
Treatment
NO INFORMATION REPORTED
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