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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
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Hernia (2240)
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 via journal article, ¿collagen-coated vicryl mesh is not a suitable material for repair of diaphragmatic defects¿ that collagen-coated mesh (ccvm) was used in the repair of diaphragmatic defects in a patient. The mesh was used as a reinforcement of the resutured muscle flap on a full-term baby girl that was admitted with a left congenital diaphragmatic hernia (cdh). At the time of her initial operation, she had agenesis of the left hemidiaphragm. She underwent multiple repair of the hernia due to multiple recurrences. Five years later, she was again admitted with recurrent cdh. During operation, a defect in the medial side of the flap was noted. The muscle flap was mobilized and was sutured to the central tendon of the diaphragm. The repair was reinforced by a sheet of ccvm that was stitched over the repair line. She made an uneventful postoperative recovery. The chest x-ray showed an intact diaphragm. At the last follow-up (8 months postoperatively) she was asymptomatic, but her chest x-ray showed a small recurrence.

 
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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 08876 0151
Manufacturer (Section G)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7149482
MDR Text Key95872399
Report Number2210968-2017-71992
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK810428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/01/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/27/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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