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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM; MESH, SURGICAL

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STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM; MESH, SURGICAL Back to Search Results
Catalog Number 2025002
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Adhesion(s) (1695); Hernia (2240)
Event Date 12/28/2018
Event Type  Injury  
Manufacturer Narrative
A investigation into lot s11242 resulted in no remarkable findings with no processing deviations or nonconformance's revealed.219 devices released to finished goods for lot s11242, 219 have been distributed.Of the 219 distributed, 97 have been reported as implanted.Lot s11242 was aseptically processed, terminally sterilized and met all qc release criteria.No other complaints reported for this lot.
 
Event Description
Patient representative reported that a male patient had strattice implanted for a hernia repair on (b)(6) 2013.Five years post operation, patient was diagnosed with adhesions, and an explant of the strattice on (b)(6) 2018.Lot number: s11242-081 and catalog 2025002.
 
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Brand Name
STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM
Type of Device
MESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key12061394
MDR Text Key264860908
Report Number1000306051-2021-03023
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number2025002
Device Lot NumberS11242
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/04/2021
Initial Date FDA Received06/24/2021
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 Age63 YR
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