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

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

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

Event Date 11/02/2019

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.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.May we have a copy of operative notes from the initial surgery? the patient demographic info: age, weight, bmi at the time of index procedure? date of initial surgical procedure? other relevant patient history/concomitant medications and procedures? product code and lot number? onset of bowel and urinary dysfunction from the time of initial surgery? please specify urinary dysfunction? date, indication and surgical findings of mesh removal? was there any deficiency or anomaly of the mesh? if yes, please describe it what is physician¿s opinion as to the etiology of or contributing factors to these events? what is the patient's current status after mesh removal? were all symptoms resolved?.

Event Description

It was reported that the patient underwent a hysteropexy surgical procedure on unknown date and unknown mesh was implanted.It was reported that the patient experienced severe pelvic pain, walking difficulties/loss of mobility, loss of sexual function, severe bowel dysfunction, constipation and urinary dysfunction and underwent a midline laparotomy, removal of mesh.Additional information has been requested.

• 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: 9522304
• MDR Text Key: 189025288
• Report Number: 2210968-2019-91341
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• 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