MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; GOWN,POLYRNF,L,100/CS

Model Number	SPT-2201CS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Chemical burn requiring presciption treatment.
Additional Manufacturer Narrative
According to the customer, a tech was using the gown in decontamination when it experienced "leaking." it was reported that due to this, "chemical were against her skin for hours as she worked." this occurred primarily on the forearms but also on the front of the gown.After the incident occurred, the customer washed her arms.It was reported that on (b)(6) 2023 she went to the emergency room for pain.According to the customer, she was prescribed medications including, "diclofenac, famotidine, loratadine, ondansetron and prednisone." a sample from the same lot was returned for evaluation.The root cause of the event was determined to be misuse of the product.It has been determined that the reported event caused or contributed to serious injury therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
The root cause of the event was unconfirmed with the received sample.

• Brand Name: MEDLINE
• Common Device Name: GOWN,POLYRNF,L,100/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16432771
• Report Number: 1417592-2023-00071
• Device Sequence Number: 20302397
• Product Code: FYA
• UDI-Device Identifier: 10884389029701
• UDI-Public: 10884389029701
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SPT-2201CS
• Device Catalogue Number: SPT-2201CS
• Device Lot Number: 20220812A14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown