MAUDE Adverse Event Report: ETHICON INC. GYNECARE PROLIFT* TOTAL PELVIC FLOOR REPAIR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PFRT01

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Bleeding (1738); Fistula (1862); Incontinence (1928); Unspecified Infection (1930); 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 by an attorney that a patient underwent a posterior pelvic floor repair procedure to treat a rectocele and enterocele in (b)(6) 2007 and mesh was implanted.In (b)(6) 2009, the patient complained of feeling uncomfortable when sitting, during bowel movements and vaginal spotting.The patient was diagnosed with recurrent prolapse and underwent surgical repair without mesh.Further recurrence of the prolapse noted in (b)(6) 2009.In (b)(6) 2010, the patient had symptoms of fecal incontinence as result of prolapse.In (b)(6) 2011, the patient underwent a modified colpocleisis procedure due to presence of mesh noted in the vagina.The patient had vaginal bleeding and continued to have problems defecating and underwent rectopexy with mesh in (b)(6) 2012.In (b)(6) 2013, the patient was admitted for genital prolapse.Mesh was noted to be descending into vagina and was re-secured.A postoperative e coli sepsis infection developed which was treated with antibiotics and pr and pv bleeding occurred.A recto-vaginal fistula was confirmed and patient underwent a colostomy in (b)(6) 2013.No additional information was provided.

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.

Manufacturer Narrative

(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON SARL - NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: ellen reuss ; route 22 west po box 151; somerville, NJ 08876 ; 9082183095
• MDR Report Key: 3597345
• MDR Text Key: 4089655
• Report Number: 2210968-2014-01160
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2010
• Device Catalogue Number: PFRT01
• Device Lot Number: 3047400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2007
• 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