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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH WN
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ASPIDE MEDICAL SURGIMESH WN Back to Search Results
Model Number T1015-8
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Wound Dehiscence (1154); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Event Description
We were informed by the company "ethicon" that they received the following event: it was reported by the nurse practitioner that the patient had a hernia repair on (b)(6) 2018 and has had impaired wound healing and a wound vac, due to wound dehiscence. The customer states a strap25 device & surgimesh- mesh product was used in the procedure. Nurse practitioner also reported patient experienced an allergic reaction to mesh used in hernia repair, surgimesh, lot f14441a ref (b)(4), unknown if any product is available for testing.
 
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Brand NameSURGIMESH WN
Type of DeviceSURGIMESH WN
Manufacturer (Section D)
ASPIDE MEDICAL
246 allée lavoisiser
la talaudiere, 42350
FR 42350
Manufacturer Contact
tadjer sid ahmed
246 allée lavoisier
la talaudiere, 42350
FR   42350
MDR Report Key8202958
MDR Text Key131647657
Report Number3006617478-2018-00007
Device Sequence Number1
Product Code FTM
UDI-Device Identifier03700296903883
UDI-Public03700296903883
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061445
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Nurse Practitioner
Type of Report Initial
Report Date 12/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/15/2022
Device Model NumberT1015-8
Device Catalogue NumberT1015-8
Device Lot NumberF14441A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2017
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: 12/28/2018 Patient Sequence Number: 1
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