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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 Problems Vomiting (2144); Hernia (2240); Not Applicable (3189)
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. (b)(4).

 
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 on a baby boy born at (b)(6) weeks¿ gestation admitted with a left cdh. He was operated on the (b)(6) day of life. During laparotomy, he was noted to have agenesis of the left hemidiaphragm. The defect was repaired with ccvm. The patient recovered after surgery and was discharged (b)(6) days after operation. At the (b)(6) postoperative week, he was admitted because of vomiting. Examination of the chest showed decreased air entry on left side with mediastinal shift. X-ray of the chest confirmed recurrence of cdh. During surgery, there was no sign of ccvm, and the defect in the diaphragm was persistent. A biopsy specimen was obtained from the periphery of the original repair. The diaphragm was repaired by anterior abdominal muscle rotation flap. The postoperative recovery was uneventful. The histology findings showed a stitch granuloma and fibrous tissue suggesting complete absorption of ccvm and very minimal growth of fibrous tissue.

 
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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 Key7149527
MDR Text Key95896297
Report Number2210968-2017-71993
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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