MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 18IN 4-0 S/A PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z513G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Purulent Discharge (1812); Erythema (1840); Hematoma (1884); Unspecified Infection (1930); Breast Discomfort/Pain (4504); Swelling/ Edema (4577)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a breast procedure on (b)(6)2023 and suture was used.The patient developed signs of infection.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(6).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.H6 component code: g07002 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.Additional information was requested, and the following was obtained: date: 3/22/2023 pt id: al procedure: implant removal, bilateral; mastopexy anchor, bilateral other complication: l breast hematoma suture: pds other relevant pt history (htn, diabetes, smoker, previous mrsa or staph inf.): pt hx of mastitis/father and sister have factor 5 age: 37 gender: f weight: 156 height (in): 5'9'' pre-op cleansing procedure: shower with hibiclens preexisting inf.Signs/symp: no surgical approach: open tissue in which suture was used: breast skin pre-op tissue condition: normal suture deficiency noted by surgeon during procedure(s): no peri-operative abx: yes, 30" prior to incision, po x 5 days postop onset date/time inf.: 11-apr drainage type/amount: yellow pus inf.Signs/symp: red/tender/painful/swelling/ separation cultures performed? (add details, if yes- need lab record): yes: grew pseudomonas other details: 3/27 pt presented with l hematoma, drained and sutured 3/29.4/11-l breast t incision swelling/pain/redness and drainage to site.Began abx.4/17 cultured wound.Results noted.5/3 closure sx.Failed.5/17 exploration of l breast.Topical wound care only: dakins and gauze/telfa dressings po antibiotics: cipro x10 days x2 return to or (y or n): y current status: polysporin/bandaid until wound healed.Rtc 1 mo.

• Brand Name: PDSII VIO 18IN 4-0 S/A PS-2 PRM MP
• 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 ; 9083863534
• MDR Report Key: 17295521
• Report Number: 2210968-2023-04936
• Device Sequence Number: 3996015
• Product Code: NEW
• UDI-Device Identifier: 10705031061354
• UDI-Public: 10705031061354
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2023

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: Z513G
• Device Catalogue Number: Z513G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 71 KG