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

Model Number 39099

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/01/1980

Event Type  Injury  

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 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
• 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 ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 11105782
• MDR Text Key: 224747980
• Report Number: 1423537-2021-00584
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10192253010473
• UDI-Public: 10192253010473
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 39099
• Device Catalogue Number: 39099
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/11/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other