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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 Problems Hemorrhage/Bleeding (1888); Pain (1994); Seroma (2069); Hernia (2240)
Event Date 12/03/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint #:(b)(4). If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. 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 any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? if so, please specify. Does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Patient demographics? (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. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation:hernia (2019) 23:299¿303 https://doi. Org/10. 1007/s10029-018-1869-y.
 
Event Description
It was reported via a journal article: title: feasibility of totally extraperitoneal (tep) laparoscopic hernia repair in elderly patients a retrospective study that reviewed clinical records of inguinal hernia patients who had undergone hernia repairs by experienced surgeons from august 2007 to september 2016. A total of 425 cases were documented. The patients were divided into two groups according to age: one group included 317 (74. 6%) patients who were younger than 70 years and the other group included 108 (25. 4%) patients those aged 70 years and older. The average follow-up period was 7 days after the surgery. A 10-mm blunt-tip trocar (ethicon)was inserted into the preperitoneal space with insufflation of carbon dioxide to a pressure of 10¿12 mmhg. Under direct endoscopic vision, a 5-mm trocar (ethicon) port was placed directly above the symphysis pubis. The extraperitoneal space was dissected and created by endodissectors with diathermy. Dissection of the hernia sac was performed to expose the spermatic cord/round ligament and all hernia orifices. After dissection of the inguinal region and reduction of the hernia sac was completed, a mesh prosthesis 12 × 9 or 13 × 10 cm, prolene mesh (ethicon) was inserted to cover all potential hernia orifices. The mesh fixation was done with endoscopic tacks. The patients were transferred to the postanesthesia recovery room for observation before returning to the hospital ward. The patients were usually discharged the next day. Reported postoperative complications in younger than 70 years patients bleeding (n
=
2) ,dysuria (n
=
20), seroma (n
=
6) and recurrence (n
=
1). Postoperative complications in aged 70 years and older bleeding (n
=
1) ,dysuria (n
=
11), seroma (n
=
1), recurrence(n
=
2). The length of hospital stay in elderly group was longer than that in the younger group. In conclusion laparoscopic tep hernia repair can be performed safely in elderly patients without differences in perioperative complications and recurrence rate compared to that in a younger population despite a longer hospital stay.
 
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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 Key11710649
MDR Text Key263098134
Report Number2210968-2021-03665
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeKS
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,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2021
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2021
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: 04/22/2021 Patient Sequence Number: 1
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