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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS VERITAS MESH, SURGICAL

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SYNOVIS SURGICAL INNOVATIONS VERITAS MESH, SURGICAL Back to Search Results
Catalog Number RM1225
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Pain (1994); Seroma (2069); Malaise (2359); Skin Inflammation (2443)
Event Type  Injury  
Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
A patient experienced a small seroma, pain, redness, not feeling well and itching after undergoing a surgical procedure in which veritas was used. The patient had undergone a bilateral breast reconstruction surgery where tissue expanders were removed and replaced with allergan implants and veritas. Six weeks post operatively (post-op) the patient developed a small seroma and was not feeling well. One week later, the patient experienced pain, inflammation, redness and itching to the whole breast area. As a result, the implants and the veritas were surgically removed. No further detail was provided regarding any further medical intervention or regarding the patient¿s outcome from the event. No additional information is available.
 
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Brand NameVERITAS
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
SYNOVIS SURGICAL INNOVATIONS
saint paul MN
Manufacturer (Section G)
SYNOVIS SURGICAL INNOVATIONS
2575 university ave w
saint paul MN 55144
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7190857
MDR Text Key104322065
Report Number1416980-2018-00147
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K062915
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberRM1225
Device Lot NumberSP16K21-1198642
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2018
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

Patient Treatment Data
Date Received: 01/15/2018 Patient Sequence Number: 1
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