MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 8X18IN 0 S/A CTB-1 CR; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDPB740D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Hernia (2240); Unspecified Tissue Injury (4559)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).(b)(4).Device not returned.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Did the suture break during the procedure (intra-op)? did the suture break post op? if yes, how many days post op? was there any precipitating stress factor for the suture breakage? please describe any medical/surgical intervention required for this suture event including dates and results.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what tissue was being approximated/ sutured? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? how was the suture originally tied (multiple knots, square knot, etc.)? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors of the suture breakage? what is the patient's current status? lot number? this is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name: irgacare®.Active ingredient(s): triclosan.Dosage form ¿ suture/solid/parenteral.Strength: = 2360 g/m.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.When the levator ani muscle was sutured with the product, the suture broke and then the tissue ruptured, leading the patient getting a hernia.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4), date sent to the fda: 6/22/2022.H6 component code: g07002 - device not returned.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: requested the following information via pcp.Was there any medical or surgical intervention performed? any update to the patient's current condition? additional information was requested, and the following was obtained: did the suture break during the procedure (intra-op)? =>post op.Did the suture break post op? if yes, how many days post op?=>yes.Dr said the suture break 4-6 weeks post op (or 8 weeks post op).Was there any precipitating stress factor for the suture breakage?=>unknown please describe any medical/surgical intervention required for this suture event including dates and results.=>now sales rep is checking it.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure=>unknown.Date and name of index surgical procedure?=>miles' operation.The diagnosis and indication for the index surgical procedure?=>unknown.What tissue was being approximated/ sutured?=>levator ani muscle.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)?=>it's according to miles' procedure.What was the tissue condition (normal, thin, calcified, fragile, diseased)?=>unknown.How was the suture placed (interrupted or continuous)?=>unknown did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation?=>unknown.How was the suture originally tied (multiple knots, square knot, etc.)?=>unknown.What symptoms did the patient experience following the index surgical procedure? onset date?=>patient got a hernia.Other relevant patient history/concomitant medications?=>unknown what is the physician¿s opinion as to the etiology of or contributing factors of the suture breakage?=>unknown.What is the patient's current status?=>the patient is almost no problem.Lot number?=>unknown this is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare active ingredient(s)- triclosan dosage form - suture/solid/parenteral strength - = 2360 g /m.
Additional Manufacturer Narrative
Product complaint #: (b)(4).H6.Component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.The following information was requested, but was unavailable: "was there any medical or surgical intervention performed? unknown.Any update to the patient's current condition? unknown.No further information will be provided.This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®; active ingredient(s) ¿ triclosan; dosage form ¿ suture/solid/parenteral; strength ¿ = 2360 g/m.

• Brand Name: PDS+ VIO 8X18IN 0 S/A CTB-1 CR
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14415249
• Report Number: 2210968-2022-03752
• Device Sequence Number: 5451790
• Product Code: NEW
• UDI-Device Identifier: 10705031218840
• UDI-Public: 10705031218840
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PDPB740D
• Device Catalogue Number: PDPB740D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 04/22/2022; 06/24/2022; 07/01/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 06/22/2022; 06/24/2022; 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown