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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH XB MESH, SURGICAL, POLYMERIC

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ASPIDE MEDICAL SURGIMESH XB MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SURGIMESH XB
Device Problem Use of Device Problem (1670)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 10/05/2017
Event Type  Injury  
Event Description
The patient had an open umbilical hernia repaired by (b)(6) md, (b)(6) hospital, using surgimesh xb ck-7 on (b)(6) 2017. Subsequently the patient developed a bowel obstruction. (b)(6), md re-operated laparoscopically and found adhesions between the bowel, abdominal wall, xb tintrack7 and other loops of bowel. The xb tintrack7 was noted to not be flat against the abdominal wall. After carefully lysing all adhesions without developing any enterotomies, dr. (b)(6) repaired the hernia with another umbilical type of mesh. The patient recovered from surgical procedure.
 
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Brand NameSURGIMESH XB
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ASPIDE MEDICAL
246 allee lavoisier
la talaudiere, 42350
FR 42350
Manufacturer (Section G)
ASPIDE MEDICAL
246 allee lavoisier
la talaudiere, 42350
FR 42350
Manufacturer Contact
sid ahmed tadjer
246 allee lavoisier
la talaudiere, 42350
FR   42350
MDR Report Key7099277
MDR Text Key94223546
Report Number3006617478-2017-00006
Device Sequence Number1
Product Code FTL
UDI-Device Identifier03700296903265
UDI-Public03700296903265
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/11/2019
Device Model NumberSURGIMESH XB
Device Catalogue NumberTINTRACK7
Device Lot NumberF13790A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2014
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: 12/08/2017 Patient Sequence Number: 1
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