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

Catalog Number PROLIFTUNK

Device Problem Migration (4003)

Patient Problems Erosion (1750); Unspecified Infection (1930); 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.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.The patient demographic info: age, weight, bmi at the time of index procedure? date, indication and name of initial surgical procedure? other relevant patient history/concomitant medications? product code and lot number? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? onset of infection from the initial surgery? location and severity of infection? were cultures performed? results? what medical intervention was performed for infection? results? when was the mesh exposure first noted by a physician? diagnostic confirmation of mesh erosion? date and surgical findings of mesh excision? what is physician¿s opinion as to the etiology of or contributing factors to these events (vaginal erosion and infection)? what is the patient's current status?.

Event Description

It was reported that the patient underwent an unknown gynecological surgery on unknown date and the mesh was implanted.It was reported that the patient experienced mesh erosion to the vaginal skin after implantation and had pain.The excision of mesh was performed.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
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9513421
• MDR Text Key: 187591049
• Report Number: 2210968-2019-91265
• 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,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PROLIFTUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2019
• 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