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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 09/28/2016
Event Type  Injury  
Manufacturer Narrative
A investigation into lot sp100247 resulted in no remarkable findings and no deviations and one unrelated nonconformance revealed.(b)(4) devices released to finished goods for lot sp100247, (b)(4) have been distributed.Of the (b)(4) distributed, (b)(4) have been reported as implanted.No other complaints against lot sp100247 were revealed.Lot sp100247 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) 2015 for a hernia repair.Patient returned to hospital on (b)(6) 2016 and diagnosed with incisional hernia.Strattice mesh removed at that time.Lot known sp100247.
 
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Brand Name
STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM
Type of Device
MESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key12034776
MDR Text Key262632750
Report Number1000306051-2021-03015
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00818410010119
UDI-Public00818410010119
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 Received06/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1016002
Device Lot NumberSP100247
Was Device Available for Evaluation? No
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age51 YR
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