MAUDE Adverse Event Report: HALYARD HEALTH SCRUB PANTS/LARGE

Model Number	991069702
Medical Device Problem Code	Electromagnetic Compatibility Problem (2927)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record is in-progress.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 8-nov-17 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the patient underwent an mri scan while wearing disposable scrub pants.It was alleged that the patient sustained skin burns on the hips and legs during the mri.Per additional information received 8 nov 2017, the mri scan was of the cervical spine.The patient's skin and the material of the scrub pants became scorched.The patient was burned on the inner side of the right breast.No further information has been provided to halyard at this time.
Additional Manufacturer Narrative
The safety information of the fabric was reviewed, the test results don't indicate a potential for dermal irritation or sensitization.The scrub suit involved in this event is not recommended for the application of mri.Scrubs are normally worn by health care personnel.However, given the scrub is made of the same polypropylene fabric as the exam gowns, there is no known connection between the scrub and this injury.All information reasonably known as of 15 dec 2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

• Brand Name: SCRUB PANTS/LARGE
• Common Device Name: SCRUB PANTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7011158
• Report Number: 3011270181-2017-00009
• Device Sequence Number: 648522
• Product Code: LYU
• UDI-Device Identifier: 30680651697029
• UDI-Public: 30680651697029
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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
• Operator of Device: Other Health Care Professional
• Device Model Number: 991069702
• Device Catalogue Number: 69702
• Device Lot Number: CA5067006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 12/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Weight: 68