MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUTURE 27"(70CM) 0 VIO; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDPB340
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts will be made to obtain the following information.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure date and name of index surgical procedure? were any concomitant procedures performed? the diagnosis and indication for the index surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition? (normal, thin, calcified, fragile, diseased?) how was the suture placed? (interrupted or continuous?) how long after the initial procedure was the suture deterioration noticed? please clarify what is meant by suture deterioration.Does this mean the suture broke? please describe any medical/surgical intervention required for this suture event including dates and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? product lot number? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Component code: (b)(4) device not returned.Trade name: (b)(4), active ingredient(s): triclosan, dosage form: suture/solid/parenteral, strength :2360 g/m.Related events reported via: 2210968-2021-05335.
Event or Problem Description
It was reported that a patient underwent an unspecified cervical cerclage procedure on an unknown date and suture was used during circumferential suturing of the cervix.About 4 months later, in the outpatient department, it was confirmed that the suture remained.But after another week, the suture could not be confirmed, and the cervical canal had been loosened.The suture was deteriorated.The patient has been hospitalized for safety.Additional information will be requested.

• Brand Name: PDS PLUS SUTURE 27"(70CM) 0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11952900
• Report Number: 2210968-2021-05334
• Device Sequence Number: 17147645
• Product Code: NEW
• UDI-Device Identifier: 10705031048799
• UDI-Public: 10705031048799
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2021

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
• Operator of Device: Health Professional
• Device Model Number: PDPB340
• Device Catalogue Number: PDPB340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/07/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization