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 08/21/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Attempts are being made to receive a device.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?.

Event Description

It was reported that the patient underwent a cervical cerclage procedure on (b)(6) 2021 and the suture was used.On (b)(6) 2021, it was found that the cervical secretion contain escherichia coli + and the patient was isolated by single contact.After antibiotic treatment, the vaginal secretion was reexamined on (b)(6) 2021 with negative bacterial culture.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 10/27/2021.A manufacturing record evaluation was performed for the finished device batch qebchl, enrs2215 and no non-conformances were identified.Additional h6 component code: g07002 ¿ reported condition not confirmed.Additional h-3 summary: a sealed packet of product code rs22 was received for evaluation with the packaging closed, the sample was examined for visual defects: appearance, color package, wrinkles in the seal area, continuous seals, seal margins, over-sealing, damage (torn, punctured) and none was observed.The packet was opened, and the swage and attachment area were noted to be as expected.During the visual inspection the tape was correctly placed on winding former.The tape was dispensed without problems and examined along and no defects, damaged on surface could be observed.Attempts are being made to receive a device.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 additional information was requested, and the following was obtained: the patient demographic info: age, gender, weight, bmi at the time of index procedure? female.Product lot number? qebchl.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? if yes, please specify.The patient was isolated by single contact, antibiotic treatment post -op what is the patient¿s current status? stable, the vaginal secretion was reexamined on (b)(6) with negative bacterial culture.The following information was requested, but unavailable: 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.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 physician¿s opinion as to the etiology of or contributing factors to this event (bacterial infection)? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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
• MDR Report Key: 12508545
• MDR Text Key: 272575677
• Report Number: 2210968-2021-08720
• Device Sequence Number: 1
• Product Code: KDC
• UDI-Device Identifier: 10705031049802
• UDI-Public: 10705031049802
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 10/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention