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 Fever (1858); Premature Labor (2465); Blood Loss (2597)

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: j pak med assoc.2012; 62 (6).(b)(4).

Event Description

It was reported via journal article: title: "morbidities of cervical cerclage: experience at a tertiary referral center." authors: saba mubasshir, shama munim, ghulam zainab.Citation: j pak med assoc.2012; 62 (6).The objective of the study was to determine the frequency of operative morbidities of cervical cerclage.A total of 70 women (age: 29.4 ± 5.2 years) undergoing cervical cerclage from april 2007 to december 2009 at the aga khan university hospital served as the study subjects.The surgical technique used was mcdonald's cervical suture using mersilene tape (ethicon) under general anesthesia.Reported complications included premature rupture of membranes (n-7) which were managed conservatively, fever (n-3) which was managed conservatively, pre-term labor (n-14) which were managed conservatively by giving progesterone suppositories by vaginal/rectal route, and vaginal bleeding (n-6) which were managed conservatively with bed rest and vaginal progesterone 400 mg daily.The results indicated that the risk of morbidities like ruptured membranes and chorioamnionitis remained small, but the risk of pre-term delivery was high.Sample size was a limitation in the study and larger study is required for subgroup analysis and for external validity.

• 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: 8090651
• MDR Text Key: 127940829
• Report Number: 2210968-2018-77253
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: PK
• 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: 11/06/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 11/20/2018
• 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