MAUDE Adverse Event Report: CIRPRO DE DELICIAS S.A. DE C.V. SMARTGOWN, LARGE, BNS 520/CS; GOWN, SURGICAL

Catalog Number	89015N
Health Effect - Clinical Codes	Swelling (2091); Urticaria (2278)
Date of Event	04/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided, therefore the device history record (dhr) was able to be reviewed.The product was manufactured january 23rd, 2017.No quality issues were reported.The sample was not available for evaluation.Without the sample (and based off of the dhr), the issue could not be confirmed, and a root cause was not determined.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.No corrective action will be taken at this time, however we will continue to monitor for complaints of this nature.
Event or Problem Description
Female certified surgical technician (cst) apparently reported that she had hives on her hands and wrists when she took off the gown and gloves.Possible discomfort also at neck area where gown contacts the skin.Her wrists became swollen the next day and she went to a physician.She was put on steroids and h2 blockers to help with the reaction.No other information about the certified surgical technician cst (age, weight, allergy history) or about the event were provided.

• Brand Name: SMARTGOWN, LARGE, BNS 520/CS
• 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: 6508117
• Report Number: 1423537-2017-00083
• Device Sequence Number: 16551076
• Product Code: FYA
• UDI-Device Identifier: 10885380003806
• UDI-Public: (01)10885380003806
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2017

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: Other Health Care Professional
• Device Expiration Date: 01/22/2022
• Device Catalogue Number: 89015N
• Device Lot Number: 0237HD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 04/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other