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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM MESH, SURGICAL

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STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 1016002
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hernia (2240)
Event Date 09/29/2017
Event Type  Injury  
Manufacturer Narrative
An investigation into lot sp100477 resulted in no remarkable findings with one unrelated processing deviation and no nonconformance's revealed. Lot sp100477 was aseptically processed, terminally sterilized and met all qc release criteria. Two other legal complaints reported for this lot. As of 7/21/21, of the (b)(4) devices released to finished goods for lot sp100477, (b)(4) have been distributed. Of the (b)(4) distributed, (b)(4) have been reported as implanted.
 
Event Description
It was reported that the patients legal representative that a (b)(6) male underwent a hernia repair surgery on (b)(6) 2017 and was implanted with strattice lot sp100477-112. The patient returned to the hospital on (b)(6) 2017 and was diagnosed with a recurrent ventral incisional hernia repair requiring revision surgery.
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key12204814
MDR Text Key267247610
Report Number1000306051-2021-03043
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
Type of Report Initial
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1016002
Device Lot NumberSP100477
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/21/2021 Patient Sequence Number: 1
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