MAUDE Adverse Event Report: ETHICON INC. ANTERIOR PELVIC FLOOR REPAIR S; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PFRA01

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

Patient Problems Adhesion(s) (1695); Inflammation (1932); Pain (1994); Weakness (2145); Not Applicable (3189)

Event Date 08/28/2008

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a richter¿s surgical procedure to treat prolapse on (b)(6) 2008 along with levator myorrhaphy and anal sphincter repair and the mesh was implanted.It was also reported that on (b)(6) 2018, abdominal pain occurred suddenly without any notion of effort, without favoring factor and transfix.Ct scanner revealed diffuse peritoneal effusion of medium to large abundance associated with a defect of enhancement of several small loops in peri-umbilical and pelvic situation evoking ischemic suffering.Since 2010, weakness of both legs which is accentuated.Currently, the patient is experiencing vaginal pains, burn, irritations, inflammations, pains in the right of the pubis during the night and lumbar pain/sciatica.Since 2010, weakness of both legs which is accentuated.The patient was hospitalized in absolute emergency for exploratory laparotomy to release adhesions and reintegrations of small loops in the abdomen due to previous operations.No further information is available.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ANTERIOR PELVIC FLOOR REPAIR S
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8468124
• MDR Text Key: 140441672
• Report Number: 2210968-2019-79823
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2011
• Device Catalogue Number: PFRA01
• Device Lot Number: 3135684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/31/2019
• Supplement Dates Manufacturer Received: 11/10/2022; 11/29/2022
• Supplement Dates FDA Received: 11/11/2022; 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female