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

Catalog Number MESHUNK

Device Problem Migration (4003)

Patient Problems Erosion (1750); Pain (1994)

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, as she¿s only seen the patient for management of defective tvt.No further information available.The patient demographic info: age, weight, bmi at the time of index procedure? indication and name of initial surgical procedure in 2006? were there any intra-operative complications? other relevant patient comorbidities? any concurrent procedure/device implantation? date and results of laparoscopy and cystoscopy? was the mesh erosion into the vagina diagnosed and when? what medical intervention was given for the pain management? results? please specify details of any medical /surgical interventions for mesh erosion if diagnosed? product code and lot number? what is physician¿s opinion as to the etiology of or contributing factors to these events? what is the patient's current status?.

Event Description

It was reported that the patient underwent an unknown gynecological surgery in 2006 and the unknown mesh was implanted.The patient experienced mesh erosion into the vagina and chronic pain.The patient underwent a diagnostic laparoscopy and cystoscopy to determine mesh localization.The patient also has a chronic pain management.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: 9392833
• MDR Text Key: 168604987
• Report Number: 2210968-2019-90365
• 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: 12/01/2019
• 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