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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL

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STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 1010002
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hernia (2240); Insufficient Information (4580)
Event Date 02/03/2014
Event Type  Injury  
Manufacturer Narrative
Qa investigation into lot s11025 resulted in no remarkable findings and no deviations and no nonconfromances revealed. 305 devices were released to finished goods. 187 reported as implanted 305 have been distributed. No other complaints against. Lot s11025 were revealed. Lot s11025 was aseptically processed, terminally sterilized and met all qc release criteria.
 
Event Description
Patient representative reported a female patient had strattice, 1010002, implanted on (b)(6) 2012 for a ventral hernia repair. Two years later, (b)(6) 2014, patient returned to hospital and diagnosed with incisional hernia. Strattice mesh removed at that time. Lot# s11025-135.
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 10, FIRM
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key11998904
MDR Text Key256185118
Report Number1000306051-2021-03006
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1010002
Device Lot NumberS11025
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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: 06/15/2021 Patient Sequence Number: 1
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