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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 Necrosis (1971); Seroma (2069); Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
This mdr is being reported as a multiple event type for serious injury. The corresponding author has not provided additional clinical information. 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
Literature of retrospective analysis in (b)(6) comparing the use of strattice with seragyn br and tiloop bra meshes for implant-based subpectoral breast reconstruction. Strattice was use in 52 of 362 reconstructions. The authors list the details of postoperative complications in various tables of the public literature. ¿overall distribution of individual complications¿. Overall, major complications occurred in 28. 8% and minor complications in 26. 9% when adm was used. When using the prsm, major complications occurred in 14. 7% and minor complications in 15. 7%, and with the nrsm, major complications occurred in 15. 4% and minor complications in 11. 7%. Thus, the rates of major and minor complications with the use of adm are approximately twice as high as with the sms, which are similar to each other.
 
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Brand NameUNKNOWN STRATTICE
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key12042147
MDR Text Key267932660
Report Number1000306051-2021-03014
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK STRATTICE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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 Treatment Data
Date Received: 06/22/2021 Patient Sequence Number: 1
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