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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 Migration (4003)
Patient Problems Erosion (1750); Urinary Tract Infection (2120); Not Applicable (3189)
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. Citation: int urogynecol j (2005) 16: 165¿167; doi 10. 1007/s00192-004-1229-6. Adverse event 6 months post op for ethibond suture reported in medwatch # 2210968-2019-78450. Adverse event 2 months after the last treatment for prolene mesh reported in medwatch # 2210968-2019-78451. Adverse event 2 months after the last treatment for ethibond suture reported in medwatch # 2210968-2019-78452. (b)(4).

 
Event Description

It was reported via journal article: "title: complications of synthetic graft materials used in suburethral sling procedures". Authors: kwong-pang tsui, soo-cheen ng, yi-torng tee, guang-perng yeh, gin-den chen citation: int urogynecol j (2005) 16: 165¿167; doi 10. 1007/s00192-004-1229-6. This study aimed to present four unusual cases of women using different synthetic materials and the complications occurred. In the first case, a (b)(6)-year-old female patient with urodynamimc stress incontinence and uterovaginal prolapse stage ii who underwent a pubovaginal slingplasty using a patch of prolene mesh with 1-0 ethibond as suspension material. She presented with chronic urinary tract infections 6 months postoperatively. Cystoscopy revealed ethibond thread in the right side of the bladder in which it was cut using an endoscopic scissor. Two months after the last treatment, symptoms of urinary tract infection relapsed and during second cystoscopy, ethibond thread was found to be migrated into the bladder and the right end of the prolene mesh eroded. She underwent reconstruction of the anterior vaginal wall in which the lower end of the ethibond was pulled out of the paravaginal fascia and the prolene mesh was removed simultaneously. The patient was followed up regularly and she remained continent. The transabdominal procedures for the removal of the synthetic materials were difficult because the meshes caused a severe fibrosis to the surrounding tissues or the posterior rami of the pubic ramis.

 
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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 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8255214
MDR Text Key133358698
Report Number2210968-2019-78451
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
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 01/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/16/2019
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 Received01/04/2019
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: 01/16/2019 Patient Sequence Number: 1
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