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

Model Number SPT-2201CS

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Date 01/17/2023

Event Type  Injury  

Event Description

Chemical burn requiring presciption treatment.

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.

Manufacturer Narrative

The root cause of the event was unconfirmed with the received sample.

• Brand Name: MEDLINE
• Type of Device: 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
• MDR Text Key: 310129573
• Report Number: 1417592-2023-00071
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 10884389029701
• UDI-Public: 10884389029701
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other