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

Model Number	9041
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): CH-CON; f20, tower 1, everbright; shanghai 20007 0; CH 200070
• MDR Report Key: 10318181
• Report Number: 1423537-2020-00491
• Device Sequence Number: 11414017
• Product Code: FYA
• UDI-Device Identifier: 10885380156069
• UDI-Public: 10885380156069
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

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