MAUDE Adverse Event Report: CIRPRO DE DELICIAS S.A. DE C.V. SMARTSLEEVE SURGICAL GOWN, 2XL LONG; GOWN, SURGICAL

Model Number 9071EL

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

There was no sample or image available for this complaint.The report states there was a physical sample but later an email was received that indicated that the sample was discarded.The investigation was carried out with the information obtained from the customer report, lot number, and the batch record.According to the inspection record, no deviation was found in the manufacture of this particular lot.The device history record on the day of manufacturing for this particular product confirmed that the settings were within specifications.Without a physical sample or photograph illustrating the defect, it is not possible to determine the root cause of the defect in the product.The product is involved in different process of manufacturing and without any evidence of a photograph or a physical sample, it is difficult to determine the origin of the defect.Awareness documented training was provided to the employees involved in the process of this product in order to be alert about this kind of issue.We will continue monitoring our customer complaints data base for this and any other issues reported of the same nature in this catalog.

Event Description

Customer reported during procedure there was a tear in the surgical tech¿s gown.Sleeve tear was found during procedure.No treatment was required for the surgical tech.Additional antibiotics were administered to the patient prophylactically.The surgeon gave the patient keflex irrigation because of this incident due to possible contamination in addition to the cefazolin they received from anesthesia.

• Brand Name: SMARTSLEEVE SURGICAL GOWN, 2XL 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 dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 12342394
• MDR Text Key: 267267953
• Report Number: 1423537-2021-00664
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10885380063428
• UDI-Public: 10885380063428
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9071EL
• Device Catalogue Number: 9071EL
• Device Lot Number: 21CUD292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1