MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SOFT MESH; SURGICAL MESH

Catalog Number 0117009

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Abnormal Vaginal Discharge (2123); Prolapse (2475); Intermenstrual Bleeding (2665)

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent if any the device may have caused or contributed to the reported event.The medical records indicated that the discharge experienced by the patient could be related to the colpopexy mesh at the top of the cervix.A transvaginal ultrasound however was performed which indicated that "the suture at the end of the vaginal cuff appears to be calcified." due to this information it is unclear whether the cause of the patient's symptom was related to a suture vs.The soft mesh implant and/or the non-bard davol sling.With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to the patient's post op complications.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned to manufacturer.

Event Description

The following is based on a review of medical records provided to davol by the patient's attorney: on (b)(6) 2013 - the patient was diagnosed with urgency incontinence, urgency urination, lateral cystocele, urethral hypermobility, stress incontinence and vaginal prolapse.The patient underwent a laparoscopic supracervical hysterectomy, sacrocolpopexy with implant of a davol soft mesh, midureteral sling using a non-bard davol sling, cystoscopy and ureteral cannulation.No operative details provided for this procedure.On (b)(6) 2015 - patient had md office exams with complaints of yellow vaginal discharge, sometimes greenish brown for about 2 months.Patient reported she had been previously treated with cipro antibiotic with no relief.Patient was diagnosed with non-specific vaginitis.On (b)(6) 2015 - patient had a follow up visit regarding results of a transvaginal ultrasound performed 2 days prior.Per the md progress notes "reviewed prior operative report at length.Discussed may be an issue with "the mesh." patient was prescribed a vaginal hormonal cream, and per the doctors exam assessment, "discharge can occur with atrophy, but this may be related to the colpopexy mesh at the top of the cervix.She may require surgery." a transvaginal ultrasound was performed and the results indicated that "the suture at the end of the vaginal cuff appears to be calcified." on (b)(6) 2015 - patient had an md office exam with complaints of blood tinged vaginal discharge and stated she feels she needs to push her bladder up every time she voids.On exam md noted, "normal vagina with atrophy, blood-tinged discharge present, no suspicious lesions present, no masses present, grade 1 cystocele present with abrasion." patient was prescribed a vaginal estrogen cream.On (b)(6) 2015 - patient had an md office exam.The patient's vaginal discharge had decreased and per md exam notes "a moderate amount of pinkish-yellowish discharge was present.Cystocele present and abrasion almost healed." the doctor prescribed a decrease in use of vaginal hormonal cream and the patient's improvements were enough to avoid surgical intervention.

• Brand Name: SOFT MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 6460152
• MDR Text Key: 71712411
• Report Number: 1213643-2017-00211
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030864
• UDI-Public: (01)00801741030864(17)180428(10)HUXC1535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2018
• Device Catalogue Number: 0117009
• Device Lot Number: HUXC1535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2013
• 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): Other
• Patient Weight: 79