• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ASPIDE MEDICAL SURGIMESH XB MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number TINTRA E2226
Device Problem Device Issue (2379)
Patient Problem Unspecified Infection (1930)
Event Date 01/20/2017
Event Type  Injury  
Manufacturer Narrative

This manufacturer report #3006617478-2017-00004 has been prepared further to reception of the importer report (b)(4).

 
Event Description

The distributor reported the following : (b)(4) forwarded six (6) potential complaint cases on (b)(4) 2017. In interviewing the operating general surgeons and staff associated with the reports, it was determined that there was only one (1) complaint. This complaint was as follows: approximately 3 months following laparoscopic repair of a 2 cm x 2 cm hernia defect with rectus diastasis using a surgimesh xb e-2226 in which the primary defect was not closed, the patient returned with an anterior abdominal wall abscess. The surgeon involved decided to remove the xb e-2226 and close the patient's hernia defect primarily. The patient recovered uneventfully.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSURGIMESH XB
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ASPIDE MEDICAL
246 allee lavoisier
la talaudiere,
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
77531659
MDR Report Key6574688
MDR Text Key75401557
Report Number3006617478-2017-00004
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072974
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 05/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/18/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date09/26/2019
Device MODEL NumberTINTRA E2226
Device Catalogue NumberTINTRA E2226
Device LOT NumberF10267A
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 Received05/12/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/26/2014
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: 05/18/2017 Patient Sequence Number: 1
-
-