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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 Obstruction/Occlusion (2422); Post Operative Wound Infection (2446)
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. Attempts are being made to obtain the following information. To date no response has not been provided. If further details are received at a later date a supplemental medwatch will be sent. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Does the surgeon believe that ethicon products (prolene mesh and ethibond suture) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products involved? citation: techniques in coloproctology. 2019; 23: 25¿31. Doi: https://doi. Org/10. 1007/s10151-018-1913-z. (b)(4).

 
Event Description

It was reported via a journal article"title : long-term outcome of laparoscopic rectopexy for full-thickness rectal prolapse". Author : h. De bruijn¿ y. Maeda¿ k. -n. Tan ¿ j. T. Jenkins ¿ r. H. Kennedy. Citation: techniques in coloproctology. 2019; 23: 25¿31. Doi: https://doi. Org/10. 1007/s10151-018-1913-z. The aim of this study was to assess the long-term outcomes of laparoscopic rectopexy for full-thickness rectal prolapse (ftrp). A total of 80 patients (74 female and 6 male patients; age range: 23 to 96 years old; bmi: 17. 8 to 42. 6) underwent a laparoscopic rectopexy. During the surgical procedure, hypogastric nerve branches were identified and preserved in all patients. Anteriorly, the rectum was mobilized to approximately 3 cm short of a full tme dissection (midvaginal level in females). Then, ethibond excel sutures (ethicon) were used to stitch the mesorectum to the presacral fascia in the midline, with the first suture being as low as possible and the last being at the sacral promontory. The laparoscopic ventral mesh rectopexy was performed as previously described by d¿hoore, suturing the prolene mesh (ethicon) to the anterior aspect of the rectum using seromuscular stitches and the opposite end to the sacral promontory. Reported complications included small bowel obstruction (n-2) which required reoperation, wound infection (n-2) which were treated with antibiotics, loop of small bowel had been stitched to the camera port site during closure (n-1) which required reoperation, and new onset evacuation problems after surgery (n-15). Laparoscopic rectopexy is a safe operation for full-thickness rectal prolapse. The durability of the repair diminished over time, particularly for patients operated on for recurrent prolapse.

 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9271337
MDR Text Key168788007
Report Number2210968-2019-89413
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 10/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/04/2019 Patient Sequence Number: 1
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