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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 Hematoma (1884); Neuralgia (4413)
Event Date 10/18/2020
Event Type  Injury  
Manufacturer Narrative
(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: surgery 2000; 13:191-6. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
It was reported in a journal article with title: laparoscopic repair of inguinal hernia. Personal experience and literature review. Between september 1997 to june 1999, a total of 72 laparoscopic hernia repairs with tapp technique in 43 patients (41 males and 2 female), with a mean age of 57. 3 years (range 29-76 years), were included in the study. All procedures were performed placing prolene mesh (ethicon), fixed along its upper border and on the cooper's ligament. Reported complications included inguinal-scrotal hematoma (n
=
1) which required surgical drainage, and inguinal crural neuralgia (n
=
2) that resolved spontaneously within a few weeks. In conclusion, the repair via the laparoscopic route, in particular with the transperitoneal approach, can treat all types of inguinal-crural hernia (direct, indirect, femoral) and, although it is a technically demanding surgery in an anatomically complex area, we believe that, in expert hands and in particular circumstances, the technique is of relatively easy execution and of sufficiently short duration, and above all it can be an effective and safe procedure for the patient.
 
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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.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11905435
MDR Text Key266847635
Report Number2210968-2021-05081
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeIT
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 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
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 Received04/30/2021
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: 05/28/2021 Patient Sequence Number: 1
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