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

Catalog Number PROMESHUNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Hematoma (1884); Urinary Tract Infection (2120); Hematuria (2558)

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: ann acad med singapore 2006;35:875-81. (b)(4).

Event Description

Title:the effectiveness of transvaginal anterior colporrhaphy reinforced with polypropylene mesh in the treatment of severe cystocele. The aim of this retrospective study was to determine the effectiveness of transvaginal anterior colporrhaphy reinforced with prolene mesh in the treatment of severe or recurrent cystoceles by looking at their primary surgical outcomes as well as their complications. From april 2002 to december 2003, thirty-seven patients (mean age 66. 8 years, range 43-86) with severe cystoceles underwent transvaginal anterior colporrhaphy reinforced with prolene mesh. The peri-vesical fascia was then plicated in the midline, from the anterior to the posterior part of the cystocele, with a gap of at least 1 cm between the sutures, using 2-0 pds ii (polydioxanone monofilament absorbable suture manufactured by ethicon, johnson & johnson) in a continuous manner. A prolene mesh is cut to an appropriate size to cover the whole cystocele centrally. The wings of the mesh were cut 1 cm wide. The two ends of the mesh were then placed onto the fascia of the iliococcygeus muscle with an artery forceps. The central portion of the mesh was then sutured with 2-0 vicryl (polyglactin 910 braided absorbable suture manufactured by ethicon, johnson & johnson) at the 4 corners onto the peri-vesical tissues for anchoring purposes. Minimal trimming of the vaginal skin was performed and the skin was sutured with continuous 2-0 vicryl rapide (polyglactin 910 braided absorbable suture manufactured by ethicon, johnson & johnson). Complications included bladder perforation (n
=
1) which did not require further management, pyrexia (n
=
13), urinary tract infection (n
=
4), hematuria (n
=
1), asymptomatic denovo detrusor instability (n
=
2), vault hematoma (n
=
1) and pelvic abscess (n
=
1). In conclusion, transvaginal anterior colporrhaphy reinforced with a tension-free prolene mesh in the treatment of severe or recurrent cystoceles is simple, safe, easily performed and is associated with a low failure rate and morbidity.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, 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 PR 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8905980
• MDR Text Key: 154730375
• Report Number: 2210968-2019-85710
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: PROMESHUNK
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/01/2019
• 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