MAUDE Adverse Event Report: ETHICON INC. GYNECARE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

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

Patient Problem Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(4) represents the adverse event which occurred on (b)(6) 2007.(b)(4) represents the adverse event which occurred on (b)(6) 2017.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2007 and mesh was implanted due to her pelvic organ prolapse.It was reported that the patient underwent revision surgery on (b)(6) 2007 due to eroded and exposed mesh.It was reported that the patient underwent revision surgery on (b)(6) 2017.No additional information was provided.

• Brand Name: GYNECARE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• 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 PR ; *
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10244832
• MDR Text Key: 198106615
• Report Number: 2210968-2020-05083
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013718
• 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: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2020
• 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 Age: 34 YR