MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problem Migration (4003)

Patient Problems Erosion (1750); Hematoma (1884)

Event Date 11/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the following information.The patient demographic info: age, weight, bmi at the time of index procedure.The diagnosis and indication for the initial surgical procedure? product code and lot number? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is physician¿s opinion as to the etiology of or contributing factors to this event? the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? was any medical/surgical intervention performed for the hematoma? when was the mesh exposure first noted by a physician? describe any medical/surgical intervention for exposure including dates and surgical findings.What is the patient's current status? to date it has been reported that the device will not be returned.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent posterior repair and sacrospinous hysteropexy on (b)(6) 2016 and mesh was implanted.The patient returned to the theatre the same day and an unknown date due to detrusor hematoma.The patient also experienced right and left paraurethral sulcus mesh exposure.The patient underwent partial mesh excision on an unknown date.Additional information has been requested.

• Brand Name: TENSION FREE VAGINAL TAPE 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: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876
• MDR Report Key: 10905794
• MDR Text Key: 219310851
• Report Number: 2210968-2020-09255
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K974098
• 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: 11/04/2020

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: 11/04/2020
• Initial Date FDA Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention