MAUDE Adverse Event Report: ETHICON INC. GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PROSIMA

Device Problems Material Erosion (1214); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Erosion (1750); Hematoma (1884); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported in a published article that patients underwent a pelvic organ prolapse procedure on an unknown date and mesh was implanted.The short term complications experienced included hematoma, pain, urinary problems, recurrent prolapse, mesh exposure and erosion.Recurrence most frequently involved the anterior compartment.Vaginal complication was the main complication observed.The patient may have undergone a surgical repair or topical estrogen cream.Pelvic symptoms improved significantly from baseline, although the patients¿ impressions of change and sexual function were not satisfying.The analysis did not identify any relationship between vaginal complication and anatomical recurrent prolapse.Additional information was requested.

Manufacturer Narrative

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

Manufacturer Narrative

It was reported, in an article, that a patient underwent a procedure to treat pelvic organ prolapse on an unknown date and mesh was implanted.The patient experienced anatomic recurrence 6 months post procedure and was treated with application of estrogen ointment.The patient¿s current condition is reported as fine.Additional information was not provided.(b)(4).

• Brand Name: GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: mary szaro ; 9082183464
• MDR Report Key: 4887686
• MDR Text Key: 6070445
• Report Number: 2210968-2015-07770
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2015

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
• Device Catalogue Number: PROSIMA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• 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: 61 YR
• Patient Weight: 65