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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number VICRYLMSHUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Fever (1858); Foreign Body Reaction (1868); Nerve Damage (1979); Swelling/ Edema (4577)
Event Date 12/18/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4).    to date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.

 
Event Description

It was reported that a patient underwent a hernia repair procedure in (b)(6) 2017 and the mesh was implanted. After surgery, the patient went back to the doctor for the post-exam and still felt a lump in the groin, "post-op swelling, nerve damage, muscle damage, etc. ¿ for 5 months the patient complained and constantly got the same answers, until returning to the doctor to report that there was "definitely" something wrong as it felt the patient had a tennis ball in the groin. The doctor eventually said that they would put the patient back into hospital on the (b)(6) 2017 to see "why" the patient is getting this feeling. On (b)(6) 2017 the patient had to be raced into bunbury regional hospital emergency with a temp of 41. 8c. After some scans, they realized the patient had a 120mm x 100mm x70mm abscess that had burst. Whilst laying in the ct room the doctor realizing that the abscess was leaking into the patient, inserted a drain through the patient¿s right groin to drain the abscess. The patient¿s body had rejected the hernia mesh as a foreign body. The patient was on intravenous antibiotics for weeks requiring a picc line and a drain for over 3.

 
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Brand NameVICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082182213
MDR Report Key11065967
MDR Text Key223763636
Report Number2210968-2020-10253
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK810428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER
Reporter Occupation
Type of Report Initial
Report Date 12/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberVICRYLMSHUNK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2020
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/23/2020 Patient Sequence Number: 1
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