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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Date 02/16/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint (b)(4). This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. Attempts are being made to clarify the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Does the surgeon believe that ethicon products (prolene mesh, prolene suture and vicryl suture) involved caused and/or contributed to the post-operative complication (wound infection) described in the article for (b)(6) years old female? please specify. Does the surgeon believe there was any deficiency with the ethicon products (prolene mesh, prolene suture and vicryl suture) used in this procedure? if yes, please provide complete patient demographics : weight, bmi at the time of index surgery. Was this case of (b)(6) years old female discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. If available, please provide prolene mesh, prolene suture and vicryl suture product codes/lot numbers used in this case. Citation: ann r coll surg engl 2019; 101: e119¿e121 doi 10. 1308/rcsann. 2019. 0034 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. Events were submitted 2210968-2021-03069 and 2210968-2021-03070.
 
Event Description
Title: appendicitis due to incarceration within a laparoscopic umbilical port-site hernia secondary to a degree of intestinal malrotation anterior abdominal wall hernias containing the appendix are rare and are usually due to sliding variants into the inguinal region or femoral canal on the right side. These are known eponymously as amyand¿s or de garengoet¿s hernias, respectively. They are usually encountered incidentally during elective repairs, but may present with appendicitis. A case of a (b)(6) year-old woman presented with a three-day history of sharp, upper abdominal pain associated with a one-day history of diarrhoea and vomiting. Magnetic resonance cholangiopancreatography (mrcp) demonstrated a 3-mm gallstone in the neck of the gallbladder, no intraductal calculi and some oedema in the fat surrounding the. She was therefore treated as gallstone pancreatitis and discharged after five days in hospital. The patient re-presented 12 days after her previous discharge with an erythematous, incarcerated umbilical hernia arising from the umbilical port site from the previous laparoscopic sterilisation. She felt nauseous, but was not vomiting, and was passing flatus. Plain abdominal radiography showed no bowel obstruction, but sterilisation clips were noted in the pelvis. Contrast computed tomography (ct) demonstrated an incarcerated hernia with a 3-cm defect reported as containing small bowel, but without bowel obstruction. She underwent incisional hernia repair. During the procedure, an ischaemic appendix was found within an inflamed hernial sac necessitating appendicectomy. The 3-cm defect was repaired with an onlay prolene mesh (ethicon) secured with prolene sutures (ethicon). A suction drain was placed over the mesh, adipose tissue was closed with vicryl (ethicon), and clips were used for skin closure. She developed a wound infection that was managed successfully with antibiotics. The drain was removed and she was discharged four days post-surgery. It was concluded, that it is possible for the appendix to become incarcerated within laparoscopic port-site incisional hernias. In the cases previously reported, 5-mm ports were probably placed on the anterior abdominal wall proximal to the caecal pole. In the case discussed, the port site was placed over a malrotated caecal pole, resulting in this unique occurrence. Surgeons should avoid placing laparoscopic port sites directly over the caecum if the appendix remains in place. If this is necessary, even 5-mm defects should be securely closed. Radiologists should report incidental malrotation seen on imaging, as it may inform future presentations.
 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11624861
MDR Text Key259329923
Report Number2210968-2021-03068
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2021
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?
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/06/2021 Patient Sequence Number: 1
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