MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO* PART. ABSORB. MESH; MESH, SURGICAL, POLYMERIC

Catalog Number UMR3

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Blood Loss (2597); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2012 and mesh was implanted.It was reported that she experienced undisclosed injuries.It was reported that the patient underwent a revision surgery on (b)(6) 2018.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 6/9/2020.Additional information: d1,d2,d3,d4,e1,g1,g2,g5.Additional b5 narrative: it was reported that the patient experienced pain and erosion of her internal bodily tissue following the procedure.Corrected information: g1 (manufacturing site name).

Manufacturer Narrative

Date sent to fda: 6/11/2020.Additional information: d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to fda: 09/15/2020.Additional b5 narrative: it was reported that the patient experienced recurrence stress urinary incontinence and bleeding.

• 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: 9085669
• MDR Text Key: 161803040
• Report Number: 2210968-2019-87628
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: UMR3
• Device Lot Number: EG9DHCC0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention