MAUDE Adverse Event Report: ETHICON SARL GYNECARE TVT SECUR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number TVTS4

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

Patient Problems Erosion (1750); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure on an undisclosed date and an unk mesh was implanted.It was reported that the patient experienced undisclosed injuries.No additional information was provided.

Manufacturer Narrative

(b)(4).It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2007 and a mesh was implanted due to sui.No additional information was provided.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Device labeling: potential adverse events that may occur with saline-filled breast implant surgery include: reoperation, pain, wrinkling, asymmetry, implant palpability/visibility, implant removal, capsular contracture, changes in nipple and breast sensation, implant displacement/migration, implant deflation, scarring, infection, hematoma/seroma, breastfeeding complications, implant extrusion, necrosis, delayed wound healing, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy.Deflation ¿ breast implants are not lifetime devices.Saline breast implants deflate when the shell develops a tear or hole.Deflation can occur at any time after implantation, but they are more likely to occur the longer the implant is implanted.The following things may cause implants to deflate: damage by surgical instruments; folding or wrinkling of the implant shell; excessive force to the chest (e.G., during closed capsulotomy, which is contraindicated); trauma; compression during mammographic imaging; and severe capsular contracture.Breast implants may also simply wear out over time.Laboratory studies have identified some of the causes of deflation for allergan¿s product; however, it is not conclusively known whether these tests have identified all causes of deflation.

Manufacturer Narrative

Additional information.

• Brand Name: GYNECARE TVT SECUR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON SARL; puits-godet 20; neuchatel NJ 2000 ; SZ 2000
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5167436
• MDR Text Key: 28904929
• Report Number: 2210968-2015-15669
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2008
• Device Catalogue Number: TVTS4
• Device Lot Number: 2983379
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR