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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN STRATTICE; MESH, SURGICAL
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UNKNOWN STRATTICE; MESH, SURGICAL Back to Search Results
Catalog Number UNK STRATTICE
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/17/2009
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation and the lot numbers remain unknown; therefore, internal investigation into the event could not be performed.Based on the reported information, a relationship between the event and strattice cannot be determined.If additional information is reported, a follow up adverse event report will be submitted.No further actions are required as a nonconformance could not be confirmed.
 
Event Description
Patient representative reported on march 7, 2008 male patient had recurrent hernia repair with strattice and heterotopic ossification occurred.The strattice mesh was inflamed requiring removal on february 17, 2009.Lot number provided is invalid.
 
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Brand Name
UNKNOWN STRATTICE
Type of Device
MESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key12070204
MDR Text Key269579238
Report Number1000306051-2021-03024
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 Received06/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK STRATTICE
Was Device Available for Evaluation? No
Date Manufacturer Received06/04/2021
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 Age46 YR
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