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

Catalog Number	39049
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): CIRPRO DE DELICIAS S.A. DE C.V.; las virgenes industrial park,; delicias, chihuahua 33019 ; MX 33019
• MDR Report Key: 7613986
• Report Number: 1423537-2018-00210
• Device Sequence Number: 1555625
• Product Code: FYA
• UDI-Device Identifier: 10885380108693
• UDI-Public: 10885380108693
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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: 39049
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 06/19/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other