MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE; TAPE AND BANDAGE, ADHESIVE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 01/01/2012

Event Type  Injury  

Event Description

It was reported that in the literature review "surgery aimed at preventing the occurrence of wound ssi in laparoscopic colectomy.Significance of anterior umbilical procedure", one (1) patient who underwent laparoscopic colorectal surgery (lacr), was part of the treated group in the study, treatment included applying isodine gel to the umbilical area 12 hours before surgery, soak it the area and applying opsite flexifix.The patient experienced a surgical site infection (ssi) in the umbilical wound despite the mentioned treatment.It is unknown how or if the event was treated.Outcome of patient is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).Surgery aimed at preventing the occurrence of wound ssi in laparoscopic colectomy.Significance of anterior umbilical procedure.

Manufacturer Narrative

H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: OPSITE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15665522
• MDR Text Key: 302330724
• Report Number: 8043484-2022-00196
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 04/12/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention