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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 18IN 5-0 S/A P-3 PRM MP; SUTURE, SURGICAL, ABSORBABLE

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ETHICON INC. PDS PLUS VIO 18IN 5-0 S/A P-3 PRM MP; SUTURE, SURGICAL, ABSORBABLE Back to Search Results
Catalog Number PDP463H
Device Problem Material Frayed (1262)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The suture had been divided into two parts like branched hairs.No adverse patient consequences were reported.Additional information was requested.
 
Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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.The following information was requested, but unavailable: what is the 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.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.
 
Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 1/24/2023 h6 component code: g07002 no device problem found additional information: d9, h3, h6 h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one empty labeled winding former, one needle-suture and one suture piece that pertains to product code pdp463h were received for evaluation.In order to evaluate the conditions of the returned samples, no suture divided into two parts or fraying suture was observed; however, one end was broken, and two ends were cut that appear to be caused by a surgical instrument were noted.After further evaluation crimping marks were observed on the surface suture possibly caused by a surgical instrument.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.
 
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Brand Name
PDS PLUS VIO 18IN 5-0 S/A P-3 PRM MP
Type of Device
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
9083863534
MDR Report Key15901054
MDR Text Key307894630
Report Number2210968-2022-09937
Device Sequence Number1
Product Code NEW
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K061037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/24/2023
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
Device Operator Health Professional
Device Catalogue NumberPDP463H
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/21/2022
Initial Date FDA Received12/01/2022
Supplement Dates Manufacturer Received01/09/2023
Supplement Dates FDA Received01/24/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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