MAUDE Adverse Event Report: BD SANDY BD E-Z SCRUB; IMPREGNATED PREOPERATIVE SCRUB BRUSHES

Model Number	371603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported by the health professional that the user experienced a rash.Email verbatim: "we have a nurse with a rash, can you tell us what product code 371603 is made of?".
Additional Manufacturer Narrative
No additional information was provided by the allergy and asthma care of florida.Primevigilance did reach out to obtain more information with no success.Should additional information be available in the future, the complaint will be re-opened and investigated.All complaints are reviewed during monthly quality/safety meetings.In addition, complaints are trended at monthly quality data analyst meetings and quarterly plant management review meetings.
Event or Problem Description
It was reported by the health professional that the user experienced a rash.Email verbatim:"we have a nurse with a rash, can you tell us what product code 371603 is made of?".

• Brand Name: BD E-Z SCRUB
• Common Device Name: IMPREGNATED PREOPERATIVE SCRUB BRUSHES
• Manufacturer (Section D): BD SANDY; 9450 south state street; sandy UT 84070
• MDR Report Key: 12353271
• Report Number: 1710034-2021-00737
• Device Sequence Number: 17115552
• Product Code: GEC
• UDI-Device Identifier: 00382903716036
• UDI-Public: (01)00382903716036
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: Health Professional
• Device Model Number: 371603
• Device Catalogue Number: 371603
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 10/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other