MAUDE Adverse Event Report: ETHICON INC. GYNECARE UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products involved? citation: neurourol.Urodynam.33:403¿407, 2014; doi 10.1002/nau.22430.(b)(4).

Event Description

It was reported via journal article: "title : pre- and postoperative evaluation of pelvic floor muscle function in pop patients using surface electromyography and digital palpation." author: xinliang chen,1 yao gong,2 dan wu,1 xiaocui li,1 huaifang li,3 xiaowen tong,3 and weiwei cheng.Citation: neurourol.Urodynam.33:403¿407, 2014; doi 10.1002/nau.22430.This non-randomized prospective study aimed to evaluate the pelvic floor muscle (pfm) function in patients with pelvic organ prolapse (pop) pre- and postoperatively using digital palpitation and surface electromyography.Two groups were recruited for this study: surgical group (n=74; with stage ii to iv pop; age of 69.31±9.46 years) and control group (n=30; without pop but with other gynecological disorder; age of 67.37±5.56 years).The patients received modified pelvic reconstructive surgery where gynemesh-soft ps were implanted.Postoperatively, in surgical group mesh erosion was observed in three patients.The pfm function was improved 3 months after the modified pelvic reconstructive surgery in pop patients based on digital palpation and semg.

Manufacturer Narrative

Pc-000234377 date sent to the fda: 08/06/2018 additional information requested and following was obtained: were the cases discussed in this article previously reported to ethicon? no, due to no product code, could not get further information now.

• Brand Name: GYNECARE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7746884
• MDR Text Key: 115921860
• Report Number: 2210968-2018-74876
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention