MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 15X15CM; MESH, SURGICAL, POLYMERIC

Catalog Number PMM3

Device Problem Migration (4003)

Patient Problems Erosion (1750); Abnormal Vaginal Discharge (2123); Blood Loss (2597); 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.Other relevant patient history/concomitant medications.The initial approach for the index surgical procedure in 2011? any concurrent procedure/device implantation? were there any intra-operative complications? onset date of current symptoms (recurrence of prolapse, vaginal discharge and bleeding) from initial surgery? when was the mesh exposure first noted by a physician? describe any medical/surgical intervention for exposure and recurrent prolapse including dates and surgical findings.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 an abdominal hysterectomy and sacrocolpopexy in 2011 for prolapse and the mesh was implanted.The patient developed a recurrence of prolapse and vaginal discharge with some bleeding which was noticed recently.Clinically patient has a mesh erosion at the vault.An mri and discussion at mdt has been arranged.Patient will require mesh excision at some date in the future.Additional information has been requested.

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Patient codes: 3189 ¿ surgical intervention.Method code.Additional information was requested and the following was obtained: the patient demographic info: age, weight, bmi at the time of index procedure other relevant patient history/concomitant medications the initial approach for the index surgical procedure in 2011? 78 years/probably 60-70kgs/bmi not known/abdominal sacrocolpopexy followed by a vaginal repair a year later 2.Any concurrent procedure/device implantation? no 3.Were there any intra-operative complications? none ¿ repeat surgery not done yet 4.Onset date of current symptoms (recurrence of prolapse, vaginal discharge and bleeding) from initial surgery? within 12 months of surgery 5.When was the mesh exposure first noted by a physician? when she attended my clinic recently although she has been attending the pessary clinic and seen other colleagues with similar problems over the years 6.Describe any medical/surgical intervention for exposure and recurrent prolapse including dates and surgical findings.Will need total excision in due course.Discussed at our mdt and also had mri which confirms infected mesh with possible abscess cavity 7.What is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status? mesh presence.Patient is discharging pus vaginally.

• Brand Name: PROLENE MESH 15X15CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8215239
• MDR Text Key: 132040181
• Report Number: 2210968-2019-78162
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Catalogue Number: PMM3
• Device Lot Number: BAB223
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR