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 Problem Unspecified Infection (1930)

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: journal of obstetrics and gynaecology.1997; 17(1): 49-50.Doi: 10.1080/01443619750114095.

Event Description

It was reported via journal article: "title: emergency cervical circlage for cervical incompetence." authors: m.Ratnavale and k.Arumugam.Citation: journal of obstetrics and gynaecology.1997; 17(1): 49-50.Doi: 10.1080/01443619750114095 a total of 12 patients underwent emergency cervical cerclage for inevitable middle trimester abortion due to cervical incompetence at the university hospital, kuala lumpur from march 1989 to june 1992.Six patients underwent cerclage as described by mcdonald and 6 patients had a minor modification of the shirodkar method.In both methods, mersilene tape (ethicon) was used.During the modified shirodkar method, a needle carrying the mersilene tape was threaded around the cervix, commencing at the anterior incision.It was tunnelled below the cervical mucosa towards the right, coming out at the posterior incision.The process was repeated on the other side to complete the cerclage commencing anteriorly, towards the left and coming out through the posterior incision.The knot was tied posteriorly with the inflated foley catheter balloon in situ.This ensures that the knot is not excessively tight.Reported post-operative complications included evidence of infection (n-8) which required routine and prophylactic antibiotic therapy.The authors confirmed that cervical cerclage is technically possible despite the dilatation of the cervical os.The authors recommended the use of emergency cervical cerclage in the management of cervical incompetence during the middle trimester for patients who present with some dilatation of the cervix.

• 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: 8047857
• MDR Text Key: 126508889
• Report Number: 2210968-2018-77027
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• 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: 10/26/2018
• 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