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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 Pain (1994); Seroma (2069); Urinary Retention (2119); Hernia (2240)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
(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). Device not returned. 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: world journal of laparoscopic surgery (2018) 10. 5005/jp-journals-10033-1353.
 
Event Description
Title: factors guarantee competence of laparoscopic repair of inguinal hernia. This randomized controlled clinical study aims to evaluate the impact of age, type of hernia, size of the mesh used, and fixation of the mesh on the competence of laparoscopic repair of inguinal hernia. From november 2016 to july 2017, a total of 98 patients (1 female, 97 males) with inguinal hernias were included in the study. Patients were divided into two groups randomly. Group i includes 49 patients all males with mean age of 42. 87 ¿ 15. 02 years old (range 1873 years) who underwent laparoscopic tapp hernioplasty with fixation and without fixation of the mesh, and group ii includes 49 patients (48 males, 1 females) with mean age of 36. 3 ¿ 15. 18 years old (range 1877 years) who underwent laparoscopic tep hernioplasty with and without fixation of the mesh. All patients were operated upon laparoscopically using prolene mesh (ethicon). During the procedures, the mesh was in a size of 7. 5 ¿ 11 cm; doubling of mesh had been done in some cases, others tailoring of the mesh. Tailored corner of mesh was positioned infero-medially over the coopers ligament and pubic bone fixed using a secure strap, while the superior border of the mesh was fixed to posterior rectus and fascia transversalis in tapp. Single mesh, doubled mesh, and tailoring of the mesh done in some cases. In group i, fixation of the mesh was done in 46. 9% of the cases, while in group ii fixation was done in 42. 9%. Reported complications included : in group i: early postoperative complication, pain (n
=
4) needed pain medication after surgery , seroma (n
=
3), urinary retention (n
=
1) and late postoperative complication, testicular pain (n
=
1),recurrence (n
=
1) nonfixed. In group ii : early postoperative complication , pain (n
=
5) needed more pain medication after surgery seroma (n
=
3), urinary retention (n
=
2) and late postoperative complication , testicular pain (n
=
1), recurrence (n
=
1) nonfixed. Discharge on the next day due to ileus post-tapp (n
=
1). It was concluded, that there is no difference between tep and tapp, but tapp technique appears to be superior to the tep repair in patients undergoing unilateral inguinal hernia repair.
 
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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
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11712685
MDR Text Key248779280
Report Number2210968-2021-03674
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeEG
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 03/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2021
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 Received03/26/2021
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: 04/23/2021 Patient Sequence Number: 1
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