MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; C-SECTION PACK

Catalog Number DYNJ0718669C

Device Problem Fire (1245)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that there was an arch during an unknown procedure and it caused a small fire.The fire was put out right away with no patient impact and no property damage.Numerous attempts have been made to attempt to contact the facility to obtain additional information related to the incident; however no additional details were available.There was no injury reported.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.No additional information is available.A sample has not been returned for evaluation however, due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that there was an arch during a case and it caused a small fire.The fire was put out right away with no patient impact and no property damage.

• Type of Device: C-SECTION PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; norhfield, IL 60093 ; 8476434960
• MDR Report Key: 7137663
• MDR Text Key: 95620056
• Report Number: 1423395-2017-00030
• Device Sequence Number: 1
• Product Code: OHM
• UDI-Device Identifier: 10889942208852
• UDI-Public: 10889942208852
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/21/2017

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: Physician
• Device Catalogue Number: DYNJ0718669C
• Device Lot Number: 17UB5522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other