MAUDE Adverse Event Report: CH-CON AAMI 4 SMARTSLEEVE SURG GOWN XL; GOWN, SURGICAL

Model Number 9041

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

Device history record could not be verified as a lot number was not provided.No sample was available for further investigation.As there is no information given on lot number, the actual supplier could not be identified.Therefore, the root cause could not be determined.There is no additional action taken at this time, but we will continue to monitor the trend of this type of incident.

Event Description

Customer reported strikethrough of gown to physician¿s arms during a diagnostic laparoscopy and laparotomy adhesiolysis w/ lavage cholecystectomy for perforated gallbladder.There was no reported injury to physician or patient due to strikethrough.It was reported that meropenem 1g in.09% sodium chloride 50ml mbp was given to the patient at the beginning of the surgery for the perforated gallbladder infection risk so no additional antibiotics were later needed due to the strikethrough.No demographics provided.Mdr being filed for potential risk to patient.

• Brand Name: AAMI 4 SMARTSLEEVE SURG GOWN XL
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): CH-CON; f20, tower 1, everbright; shanghai 20007 0; CH 200070
• Manufacturer (Section G): CH-CON; f20, tower 1, everbright; shanghai 20007 0; CH 200070
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 10318181
• MDR Text Key: 202018857
• Report Number: 1423537-2020-00491
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10885380156069
• UDI-Public: 10885380156069
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9041
• Device Catalogue Number: 9041
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2020
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other