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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 KUGEL PATCH SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 KUGEL PATCH SURGICAL MESH Back to Search Results
Catalog Number 0010105
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Unspecified Infection (1930); Obstruction/Occlusion (2422); Ascites (2596)
Event Date 10/15/2015
Event Type  Injury  
Manufacturer Narrative
Based on the information obtained in the article, no conclusion can be made. Postoperative infection is a known inherent risk of surgery. The instructions-for-use, supplied with the device states, "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device. " and ¿care should be taken to ensure that the patch is adequately fixated to the abdominal wall. If necessary additional fasteners and/or sutures should be used. ¿ without a lot number, review of the manufacturing records cannot be conducted. Note, the information provided included months only as such the date of event is considered to be estimated of (b)(6) 2015. Note, we were unable to locate an english translation of the attached article/abstract. If/when additional information be provided, a supplemental emdr will be submitted.
 
Event Description
Per journal article, ¿a case report for mesh (kugel patch) migration into bladder after right hernia repair. ¿ source: the 85th annual meeting of the eastern section of japanese urological association (2020). Patient was diagnosed with a right inguinal hernia and underwent repair. A mesh (medium oval kugel patch) was implanted during this repair. The patient developed acute abdomen, and abdominal ct revealed free air, ascites, and intestinal obstruction. A laparotomy was performed and exposure of the mesh to the abdominal cavity was observed. It was thought to be due to mesh infection. Urine outflow was observed in the drain after surgery, and in october of the same year, a cystoscope revealed an exposure of the mesh on the right wall of the bladder. In the same month, partial bladder resection and mesh removal were performed. It is possible that the bladder was injured during hernia treatment, but since there was no problem with the postoperative course, it is highly probable that it occurred following mesh infection. The health injury to the patient was unknown.
 
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Brand NameKUGEL PATCH
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
MDR Report Key12739721
MDR Text Key279638949
Report Number1213643-2021-20387
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K963141
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature,other
Type of Report Initial
Report Date 10/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0010105
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2021
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/02/2021 Patient Sequence Number: 1
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