MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO* PART. ABSORB. MESH; MESH, SURGICAL, POLYMERIC

Model Number	UMS3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Autoimmune Disorder (1732); Diarrhea (1811); Micturition Urgency (1871); Hemorrhage/Blood Loss/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Discomfort (2330); Prolapse (2475); Abdominal Distention (2601); Dysuria (2684); Constipation (3274); Fecal Incontinence (4571); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date sent to the fda: 07/03/2023.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, 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.
Event or Problem Description
It was reported by an attorney that the patient underwent a revision surgery on (b)(6) 2007 and mesh was implanted.It was reported that the patient experienced constipation, low back pain, urine urgency, urge incontinence, nocturia, stress incontinence, vaginal discomfort, frequency, urinary tract infections, pelvic pain, rectal bleeding, cystocele, vaginal bleeding, voiding dysfunction symptoms, vaginal discharge, abdominal bloating and swelling, dysuria, leg pain, buttock pain, abdominal pain, infection, loose stools, fecal incontinence, fibromyalgia, groin pain, hip pain, hemorrhoids, atrophic vaginitis and bowel urgency the patient had a previous mesh implanted on (b)(6) 2003 which is captured in separate file.No additional information was provided.

• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17253201
• Report Number: 2210968-2023-04786
• Device Sequence Number: 5280833
• Product Code: FTL
• UDI-Device Identifier: 10705031085947
• UDI-Public: 10705031085947
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2023

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
• Operator of Device: Health Professional
• Device Model Number: UMS3
• Device Catalogue Number: UMS3
• Device Lot Number: ZD8GKXR0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female