MAUDE Adverse Event Report: ETHICON INC. PROSIMA PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Migration (4003)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

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.Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2021.Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2020.Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2021.Mwr# (b)(4), submitted for adverse event which occurred on (b)(6) 2020.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and mesh was implanted.It was reported the patient experienced pain on (b)(6) 2020 and underwent a cystoscopy.It was reported that the patient underwent a cystolitholapaxy to remove a stone from her bladder.It was reported that the patient underwent a second cystolitholapaxy in (b)(6) 2020.It was reported that the patient underwent a cystoscopy on (b)(6) 2021 and found bladder stones that were attached to the left side of the eroded mesh.It was reported that the patient underwent a cystolitholapaxy on (b)(6) 2021.No additional information was provided.

• Brand Name: PROSIMA PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13476786
• MDR Text Key: 289248947
• Report Number: 2210968-2022-00898
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/07/2022
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female