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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
Catalog Number PROMESHUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Incontinence (1928); Unspecified Infection (1930); Blood Loss (2597); 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. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation: colorectal disease (2007); 10:138¿143. Doi:10. 1111/j. 1463-1318. 2007. 01259. X. (b)(4).
 
Event Description
It was reported in a journal article with title: laparoscopic ventral rectopexy, posterior colporrhaphy and vaginal sacrocolpopexy for the treatment of recto-genital prolapse and mechanical outlet obstruction. Whilst trans-abdominal fixation resection offers better functional results and lower recurrence than perineal procedures, mesh rectopexy is complicated by constipation. Laparoscopic autonomic nerve-sparing, ventral rectopexy allows correction of the underlying abnormalities of the rectum, vagina, bladder and pelvic floor. Between january 1997 and december 2005, 80 patients (6 male and 74 female; median age: 59 years; age range: 31¿90 years; bmi: 19¿36) underwent novel laparoscopic prolapse surgery for full thickness prolapse and/or mechanical outlet obstruction. A harmonic scalpel (ethicon) is used for the dissection. A 15x15 cm prolene polypropylene mesh (ethicon) is trimmed in the hypotenuse axis to 3x17 cm, the last 7 cm tapering to 1 cm. The mesh is sutured to the ventral aspect of the seromuscular wall of the rectum using three, interrupted, non-absorbable sutures ethibond 0 (ethicon). The posterior wall of the vagina is then sutured to the ventral aspect of the mesh with three sutures as before. The most cranial is sutured to the posterior vaginal fornix. The tapered end of mesh is fixed to the sacral promontory without placing any particular traction on the rectum. During the resection rectopexy, the upper 1/3 of the rectum is divided using a linear cutter (ethicon). The umbilical port is extended either side of the umbilicus in the midline to allow delivery of the bowel. The proximal bowel and head of a circular stapling device (ethicon) is returned to the abdominal cavity and the incision is closed around the re-introduced umbilical port. Reported complications included fecal impaction (n-3), extraction port site infection (n-1), wound infection (n-2%), bleeding (n-1), resection rectopexy anastomosis leaked (n-1) which required a temporary loop ileostomy, urinary retention (n-1), minor evacuatory difficulties (n-3) which were managed with a combination of senna and enemas. And two, urinary stress incontinence (n-2) which responded to a tvt sling. In conclusion, laparoscopic ventral rectopexy is safe with relatively low morbidity. In the medium-term, it provides good results for prolapse and associated symptoms of incontinence and obstructed defecation.
 
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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
982 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 Key8906290
MDR Text Key154738414
Report Number2210968-2019-85725
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
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 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPROMESHUNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
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: 08/19/2019 Patient Sequence Number: 1
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