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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Granuloma (1876); Pain (1994); Swelling (2091); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient underwent a gynecological procedure on (b)(6) 2008 and mesh was implanted.Following the procedure, the patient experienced unspecified complications and underwent three additional surgical procedures to trim and loosen the mesh.Additional information has been requested.

Manufacturer Narrative

It was reported that the patient underwent a gynecological procedure on (b)(6) 2008 and mesh was implanted.The patient experienced swelling from vagina for 2 years, difficulty in emptying bladder and bowel and pain down right leg.The surgeon opines that a contributing factor of the patient¿s symptoms is vaginal wall laxity in a menopausal patient.The patient underwent an additional procedure on (b)(6) 2009.A granuloma in the vagina was cauterized and portions of mesh were excised in the anterior and posterior vagina compartments with cystoscopy.On (b)(6) 2010, the patient was experiencing narrowing of vagina and discomfort from posterior limb of mesh.The surgeon noted an atrophic vagina.No exposed mesh was seen but narrowing of vagina and tenderness at the vault was noted.The patient was prescribed premarin cream 1gm.(b)(4).

• Brand Name: GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM
• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5200335
• MDR Text Key: 30337396
• Report Number: 2210968-2015-17471
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: TS
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2015

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2015
• Initial Date FDA Received: 11/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2015
• 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: 60 YR
• Patient Weight: 70