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U.S. Department of Health and Human Services

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

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STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 2020002
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hernia (2240); Insufficient Information (4580)
Event Date 11/14/2014
Event Type  Injury  
Manufacturer Narrative
Qa investigation into lot s10929 resulted in no remarkable findings and no deviations and no nonconfromances revealed. (b)(4) devices were released to finished goods. (b)(4) reported as implanted (b)(4) have been distributed. No other complaints against. Lot s10929 were revealed. Lot s10929 was aseptically processed, terminally sterilized and met all qc release criteria.
 
Event Description
Patient representative reported that a female patient had strattice implanted for a hernia repair on (b)(6) 2011. On (b)(6) 2014 she had adhesions, bowel obstruction and an explant of the strattice. Lot number s10929-010 catalog 2020002.
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 20, FIRM
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key11991981
MDR Text Key267691938
Report Number1000306051-2021-03007
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
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 Received06/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2020002
Device Lot NumberS10929
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2021
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: 06/14/2021 Patient Sequence Number: 1
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