MAUDE Adverse Event Report: CIRPRO DE DELICIAS S.A. DE C.V. SMARTGOWN SURGICAL GOWN, 3XL, LONG; GOWN, SURGICAL

Model Number	39099
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/01/1980
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer did not provide the lot number, sample, or sample image for this complaint.Without the lot number, a review of the device history record could not be completed.We were unable to determine the root cause for the reported complaint without the issue sample.All production completed met the required specifications.We will continue monitoring our customer complaints data base for this and any other issues reported of the same nature in this catalog.The design group was notified of this complaint.
Event or Problem Description
Based on information received from the customer they allegedly had an adverse reaction to gown 39099.Per customer the event date was sometime between (b)(6) 2020, not aware of reaction until days later.They were seen in employee health, dermatologist and allergist.They were reportedly prescribed topical betamethasone.

• Brand Name: SMARTGOWN SURGICAL GOWN, 3XL, LONG
• 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: 11105782
• Report Number: 1423537-2021-00584
• Device Sequence Number: 4042890
• Product Code: FYA
• UDI-Device Identifier: 10192253010473
• UDI-Public: 10192253010473
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2021

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 Model Number: 39099
• Device Catalogue Number: 39099
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 01/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other