MAUDE Adverse Event Report: ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Unspecified Infection (1930); Pain (1994); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure? date and name of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? other relevant patient history/concomitant medications? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? when was the mesh exposure first noted by a physician? site/location? onset date/time of the pain from surgery? location of the pain? date - time of onset of infection from the surgical procedure? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? were cultures performed? results? please indicate if the reference you made "infected vaginal prolapse mesh" is a reference to why you had the mesh implanted which subsequently became infected or are you stated that the mesh resulted a diagnosis of vaginal prolapse? was the device removed? if so, please date and details of the re-operation.Product code and lot number? if applicable, will product be returned, return date, tracking information? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.

Event Description

It was reported that patient underwent a gynecological procedure on an unknown date and mesh was implanted.Following the procedure, the patient experienced chronic pain, exposed, infected vaginal prolapse mesh.The patient was referred to tertiary center for management and underwent a surgical "procoedure".Additional information has been requested.

• Brand Name: PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8156050
• MDR Text Key: 130079886
• Report Number: 2210968-2018-77715
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/12/2018
• 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