MAUDE Adverse Event Report: ETHICON SARL GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Cardiac Arrest (1762); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Weakness (2145); Ambulation Difficulties (2544); Abdominal Distention (2601); No Code Available (3191)

Event Date 11/22/2007

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.

Event Description

It was reported that the patient underwent an unknown gynecological procedure in 2007 and the mesh was implanted for bladder/bowel prolapse.It was also reported that the patient experienced constant uti¿s, e-coli infection and two other infections resistant to antibiotics.The patient also experienced bloating, incontinence requiring pads or pants each time; stomach, vaginal, anal, groin, thigh, hip, back, leg, sciatic and pelvic pain, wobbly legs, tingling in feet and twitches with weakness as well.The patient experienced a vaginal erosion which necessitated removal of the erosion.It was reported that bladder tests were performed to check how it was working; one was done with an anesthetic and the other one done with x-ray.The patient experienced silent heart attack, fibromyalgia, panic attacks, agoraphobia, depression, constant exhaustion, which was diagnosed as chronic fatigue.The patient also experienced dry flaky skin, hair loss, problems with teeth and eyes and loss of sexual activities.The patient was unable to walk/exercise, stand in own bathroom to blow dry hair and drive a car as well.The patient has to use estrogen patches and vaginal cream.No further information is available.

• Brand Name: GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON SARL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6770629
• MDR Text Key: 81937507
• Report Number: 2210968-2017-04754
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2017
• 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