MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 10X12CM CTN 50; TAPE AND BANDAGE, ADHESIVE

Model Number	4923
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during unknown treatment with an unspecified patch, the patient had itch, rash and 5mg dexamethasone injection was applied.It is unknown how was the procedure finished, if there was a delay and when did this occur.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as the lot number provided is not a valid lot number for this product, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history file contains further instances/ related events of the reported event.The device was used for treatment.No samples were returned for analysis.The reported issue may be related to procedural technique or underlying patient conditions.A clinical investigation concluded: ¿the information provided is insufficient to determine whether the patient¿s symptoms are due to a pre-existing or concurrent medical condition (allergy history, skin/dermal sensitivities).It was further communicated the skin was disinfected and cleaned with less thrill disinfectant, 5ml saline and a 5mg dexamethasone injection.It was reported three days later the symptoms disappeared.Since there was no delays and the issue has resolved, no further clinical/medical assessment is warranted at this time.¿ we have not been able to confirm a relationship between the event and the device or identify a definitive root cause.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: IV3000 1 HAND 10X12CM CTN 50
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11018528
• Report Number: 8043484-2020-04261
• Device Sequence Number: 869610
• Product Code: KGX
• UDI-Device Identifier: 05000223422080
• UDI-Public: 05000223422080
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4923
• Device Catalogue Number: 4008
• Device Lot Number: 20191001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR