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

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/01/2013

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: female pelvic medicine and reconstructive surgery. 2013 apr; conference: 39th annual meeting of the society of gynecologic surgeons, sgs 2013. Charleston, sc united states. Conference publication: (var. Pagings). 19 (suppl. 1) :s21-s22. Events related to prolene suture reported via mw # 2210968-2021-02831.

Event Description

It was reported in a journal article with title: natural orifice vaginal sacrocolpopexy: short-term outcomes. The objective of this study was to assess the short-term outcomes of natural orifice vaginal sacrocolpopexy with a retroperitoneal approach, using the same steps as the classical abdominal approach. Between december 2009 and august 2012, 18 patients with stage iii or iv vaginal vault prolapse and uterine prolapse were enrolled in the study. During the procedure, the presacral fascia was dissected at the level of s1 placing two to three 2-0 prolene sutures (ethicon) horizontal to the sacral portion of the anterior longitudinal ligament. These sutures were then passed through along soft macroporous prolene mesh (ethicon) and were tied with a knot-pusher. The vagina was everted and four prolene sutures were placed in the anterior vaginal wall, passed through a 5 cm wide and 6 cm long mesh and tied. Six sutures were placed in the posterior vaginal wall. The everted vagina was invaginated. Afterwards, sutures were placed in the posterior vaginal wall and passed through the graft of the sacrum superiorly and obliquely. Both anterior and posterior grafts were attached with 2-0 prolene. The sutures from the posterior vaginal wall to the sacrum mesh were tied to restore the vaginal apex to its normal position. Reported complications included mean estimated blood loss of 250 ml during surgery (range 200 ¿ 1000 ml) with mean hemoglobin reduction of 1. 5 g (range 1. 0 ¿ 3. 8 g) (n
=
?) in which 2 patients required blood transfusion. In conclusion, restoration of the vaginal apex to its normal longitudinal position was acceptable for the vaginal approach. Reproduction of the classical abdominal steps is possible with vaginal-retroperitoneal-approach.

• 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
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754 ; 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11580551
• MDR Text Key: 255352139
• Report Number: 2210968-2021-02832
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• 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 Received: 03/03/2021
• 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
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 03/29/2021 Patient Sequence Number: 1