MAUDE Adverse Event Report: CIRPRO DE DELICIAS S.A. DE C.V. SMARTGOWN, X-LARGE/X-LONG, RAGLAN; GOWN, SURGICAL

Catalog Number 39049

Device Problem Insufficient Information (3190)

Patient Problem Exposure to Body Fluids (1745)

Event Date 05/18/2018

Event Type  Injury  

Manufacturer Narrative

The customer cannot identify the exact gown worn by the resident, however it is believed that this could be the involved catalog number.The resident is no longer there, so no additional information is available.The lot number was not provided, therefore the device history record could not be reviewed.The sample was not available for evaluation.Historical trending was done for the last year, and this is the only reported incident for this product for this issue; therefore this is considered to be an isolated event.Based on the information provided and without a sample evaluation, the reported issue of strike through was unable to be confirmed.The root cause was not determined, and no corrective action taken.All finished goods are made from qualified material that is tested before use.Final finished product must meet product specification and process requirements before final release to salable inventory.We will continue to monitor complaints for issues of this nature.

Event Description

A resident got blood on his arm and down to his hand while doing an abdominal surgery.Apparently there was no hole on the sleeve.Since the resident had a blister on one finger, (b)(6) and (b)(6) testing was done on the patient.

• Brand Name: SMARTGOWN, X-LARGE/X-LONG, RAGLAN
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): CIRPRO DE DELICIAS S.A. DE C.V.; las virgenes industrial park,; delicias, chihuahua 33019 ; MX 33019
• Manufacturer (Section G): CIRPRO DE DELICIAS S.A. DE C.V.; las virgenes industrial park,; delicias, chihuahua 33019 ; MX 33019
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 7613986
• MDR Text Key: 111484311
• Report Number: 1423537-2018-00210
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10885380108693
• UDI-Public: 10885380108693
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 39049
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other