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

Catalog Number MESHUNK

Device Problem Migration (4003)

Patient Problems Erosion (1750); Pain (1994); Not Applicable (3189)

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.Additional information was requested, and the following was obtained: the surgeon has informed that she doesn't have the additional information, no further information available.The patient demographic info: age, weight, bmi at the time of index procedure? name and indication of initial surgical procedure in 2014 when mesh was implanted? other relevant patient history/concomitant medications? any concurrent procedure / device implantation? were there any intra-operative complications? when was the vaginal mesh erosion first noted by a physician? mesh erosion into vagina diagnostic confirmation? was any deficiency or anomaly of the mesh? if yes, please describe it.Onset date of pain from the initial surgery? was the chronic pain resolved after mesh removal? please provide a date and details / surgical findings of mesh removal? what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status? mesh product code and lot number implanted in 2014? if applicable, will product be returned, return date, tracking information?.

Event Description

It was reported that the patient underwent an unknown gynecological surgery in 2014 and the unknown mesh was implanted.The patient experienced mesh erosion into the vagina and chronic pain.The patient underwent a mesh removal, complex and difficult surgery.No further information is available.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9392921
• MDR Text Key: 168608674
• Report Number: 2210968-2019-90366
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MESHUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention