MAUDE Adverse Event Report: ETHICON INC. MERS TAPE WHT 12INX3/16IN D/A CTX; CLASS I DEVICE - EXEMPT

Model Number RS22

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

Patient Problem Bacterial Infection (1735)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device batch qebchl and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to receive additional information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of index procedure? product lot number? on what tissue was the suture used? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? were there any pre-existing signs/symptoms of active inflammation/infection prior to this surgical procedure? please specify.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? if yes, please specify.What medication was given to treat the infection? please specify.Did the operating surgeon observe any suture deficiency or anomaly before, during or after the suture placement? please specify.Other relevant patient history/comorbidities/concomitant medications? what is physicians opinion as to the etiology of or contributing factors to this event (bacterial infection)? what is the patients current status? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the patient underwent a cervical cerclage procedure on (b)(6) 2021 and the suture tape was used.Post-op, the patient experienced post-op infection.On (b)(6) 2021, the cervical secretion was found to contain escherichia coli + and the patient was isolated by single contact.After antibiotic treatment, the vaginal secretion was negative for bacterial culture on (b)(6) 2021.Additional information has been requested.

• Brand Name: MERS TAPE WHT 12INX3/16IN D/A CTX
• Type of Device: CLASS I DEVICE - EXEMPT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12517155
• MDR Text Key: 272855428
• Report Number: 2210968-2021-08776
• Device Sequence Number: 1
• Product Code: KDC
• UDI-Device Identifier: 10705031049802
• UDI-Public: 10705031049802
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2021

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
• Device Model Number: RS22
• Device Catalogue Number: RS22
• Device Lot Number: QEBCHL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention