MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC SMARTGOWN SPECIALITY XL XLONG RAGLAN; GOWN, SURGICAL

Catalog Number	32474
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The gown sample was received and the presence of the hole was confirmed.Evaluation of the sample indicated that the edge was hardened and a tear was present on the front of the gown at the hole.This might have resulted from a melted portion of the material that hardened and when removed, a hole resulted.No exception was recorded in the device history record, and no abnormality (that could result in the issue) was observed during the manufacturing process.Review of the complaint history indicated this type of failure is an isolated incident.The root cause could not be determined from the investigation.The complaint information was shared with the relevant sectors for their awareness, and a refresher training was conducted with the folding operators.We will continue to monitor complaints for any trends regarding this type of incident.
Event or Problem Description
A 2-3 cm circular hole was discovered in the front midsection of the gown the surgeon was wearing while performing a total knee replacement surgery.The surgeon gave the patient an extra dose of antibiotics due to the hole in the gown.

• Brand Name: SMARTGOWN SPECIALITY XL XLONG RAGLAN
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1 butterfield trail blvd; el paso TX 79906
• MDR Report Key: 6411548
• Report Number: 1423537-2017-00077
• Device Sequence Number: 932525
• Product Code: FYA
• UDI-Device Identifier: 10885380128325
• UDI-Public: 10885380128325
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/16/2017

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: Physician
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: 32474
• Device Lot Number: 16HWM028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2017
• Initial Report FDA Received Date: 03/16/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Weight: 109