MAUDE Adverse Event Report: ETHICON INC. GYNECARE PROFIX FASTENER SYSTEM; IMPLANTABLE STAPLE, NONABSORBABLE

Catalog Number PFRF01

Device Problem Implant extrusion (2154)

Patient Problems Extrusion (1844); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Retention (2119)

Event Type  Injury  

Event Description

It was reported by an attorney that a patient underwent a gynecological procedure for pelvic floor repair and reduction of an enterocele in (b)(6) 2007 and fasteners were used to secure mesh.In (b)(6) 2007, stitch material was palpable in the vaginal wall.The patient experienced urinary urgency, urge incontinence, difficulty urinating, and pain in the lower abdomen and on the left side.No further 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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: GYNECARE PROFIX FASTENER SYSTEM
• Type of Device: IMPLANTABLE STAPLE, NONABSORBABLE
• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3715126
• MDR Text Key: 4236026
• Report Number: 2210968-2014-04042
• Device Sequence Number: 1
• Product Code: PBQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042603
• 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
• Report Date: 02/20/2014

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 Expiration Date: 04/30/2007
• Device Catalogue Number: PFRF01
• Device Lot Number: 2921031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2014
• Initial Date FDA Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2006
• 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