MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,COUDE,LATEX,16FR,10ML

Catalog Number	DYND11216
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the silicone-elastomer coated latex foley catheter was placed in patient's laparoscopic-assisted diverting loop ileostomy to drain the patient's bowel and to keep the ileostomy open.Reportedly, it was known before foley catheter insertion that patient is allergic to latex; however, it was not noted prior to insertion into patient that the foley catheter is made with natural rubber latex.Approximately six days after the latex foley catheter was inserted into patient, the patient's diverting loop ileostomy was noted sloughing and with fibrino-purulent exudate present.Per report, patient required surgery to debride the ileostomy.It was added that an allergy physician consult was obtained and the ostomy care was managed by wound care services.The patient was reportedly discharged from the facility in stable condition with healthy-appearing stoma.Due to the reported event and required ileostomy debridement, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause for the reported issue is unintended user error/misuse.Information for use indicate: "silicone elastomer coated latex foley catheter", "for urological use only", "caution: this product contains natural rubber latex which may cause allergic reactions." no additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a latex foley catheter was inserted into the ileostomy of a patient(with known latex allergy).The ileostomy developed sloughing and required surgical debridement.

• Common Device Name: CATHETER,FOLEY,COUDE,LATEX,16FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8753492
• Report Number: 1417592-2019-00107
• Device Sequence Number: 11179768
• Product Code: EZL
• UDI-Device Identifier: 10080196726769
• UDI-Public: 10080196726769
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/02/2019

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 Catalogue Number: DYND11216
• Device Lot Number: 59218050434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 80