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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Urinary Retention (2119)
Event Date 09/03/2011
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.   the single complaint was reported with multiple events. There are no additional details regarding the additional events.   citation: infect inflamm rep, vol. 12, no. 3, september 2011.   event related to the prolene 3d patch mesh reported via mw # 2210968-2021-03475.
 
Event Description
It was reported in a journal article with title: experience of the use of prolene 3d patch and prolene hernia system in the repair of inguinal hernia: report of 106 cases. The objective of this study is to observe the effects of prolene 3d patch (3dp) and prolene hernia system (phs) in the repair of inguinal hernia. From january to august 2009, 106 patients with inguinal hernia that were repaired with 2 types of patches were included in the study. There were 98 males and 8 females with a mean age of 59. 4 +/- 13. 7 years (range 25 to 81 years). There were 98 cases of unilateral hernia, including 97 cases of primary hernia and 1 case of recurrent hernia. There were eight cases of bilateral hernia. There were 12 cases concomitant with chronic respiratory diseases, 4 cases with prostatic hypertrophy, 2 cases with hypertension, 4 cases with diabetes mellitus, and 4 cases with long-term constipation. For the 57 cases with small-diameter hernia ring and no obvious defect of transverse abdominal fascia, the prolene 3d patch (ethicon) was used; for the 49 patients with large-diameter hernia ring, weak or obvious defect of transverse abdominal fascia, and no serious contamination of the operative area, prolene hernia system (ethicon) was used. There were no complications of the heart, brain, and lung after the operation. The postoperative follow-up was 18 to 26 months, with an average of 20 months, with no recurrence. Postoperative complications include acute urinary retention (n
=
2), and after indwelling the catheter, spontaneous urination was restored 1 to 2 days later.
 
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Brand NamePROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11682936
MDR Text Key261984156
Report Number2210968-2021-03476
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K984220
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 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2021
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 Received03/19/2021
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

Patient Treatment Data
Date Received: 04/17/2021 Patient Sequence Number: 1
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