MAUDE Adverse Event Report: ETHICON INC. MERSILENE TAPE UNKNOWN PRODUCT; INSTRUMENT, SURGICAL, DISPOSABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Pain (1994); Hernia (2240); Discomfort (2330); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: fertil steril 2011; 96: 895¿7; doi: 10.1016/j.Fertnstert.2011.07.009.(b)(4).

Event Description

It was reported via journal article: title: "successful tubal blastocyst transfer after laparoscopic cervical cerclage: cesarean delivery of a live very low-birth-weight infant and later hysterectomy for uterine rupture," authors: andrew murray, m.B.Ch.B., f.R.A.N.Z.C.O.G., and john hutton, ph.D.Citation: fertil steril 2011; 96: 895¿7; doi: 10.1016/j.Fertnstert.2011.07.009.This study aimed to report the management of a woman who presented with secondary infertility and amenorrhea after lletz procedure and a cone biopsy and who had cervical stenosis, a foreshortened cervix and hematometra.A (b)(6) female patient desired for further children after a cone biopsy for persistent abnormal cervical cytology underwent laparoscopic cervical cerclage using 5-mm mersilene tape.At (b)(6) gestation of the second ivf, she felt slight pelvic discomfort and was admitted with 3-cm herniation of the uterus posterior above where the tape was observed together with some free fluid in the pelvis.Three days after, repeat scan showed increased herniation posteriorly and subsequently underwent emergency caesarian delivery with a male infant weighing (b)(6).A 14-fr foley catheter with 10ml balloon was inserted through cervix and considerable traction was required for its removal 7 days later.Four months later, she had moderately severe pelvic cramps and the uterus was found distended with a 5-cm hematometra.She was treated with high-dose progestogen therapy with symptomatic relief but no reduction in hematometra.Two months later, she underwent percutaneous drainage of hematometra with a recurrence of pelvic cramps.A month later, hematometra recurred with severe pain requiring hospitalization and had a lower abdominal tenderness.Ultrasound scan showed reduction of hematometra and free-fluid in the pelvis.At laparotomy, a 1-cm uterine rupture just above the suture was noted and subtotal hysterectomy with removal of the tape was undertaken.Her recovery was protracted, but after 6 months, she was eventually pain free.This patient experienced after cervical cerclage the complication of herniation of the uterus, with premature cesarean delivery and later hematometra and uterine rupture necessitating hysterectomy.The site of the uterine herniation and the subsequent rupture was posterior just above the cerclage.The cerclage was associated with imminent uterine rupture during pregnancy, necessitating premature delivery of a very low-birth-weight infant.

• Brand Name: MERSILENE TAPE UNKNOWN PRODUCT
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8102721
• MDR Text Key: 128311312
• Report Number: 2210968-2018-77330
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR