MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. NO STING SKIN PREP SPRAY JAPAN; BANDAGE, LIQUID, SKIN PROTECTANT

Catalog Number 66800872

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, at the inspection before it was used, a no sting skin prep spray, there was a crack on the spray nozzle just right out of the box.A competitor device was used.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Correction: h1 non reportable.Although this is considered a device malfunction, the issue will not cause or contribute to serious injury as a back-up / alternative device or treatment was available.In addition, use of a similar back up device/product is considered a continuation of a procedure/therapy and not an intervention to preclude serious injury.This event is not reportable pursuant to 21 c.F.R.§803.

• Brand Name: NO STING SKIN PREP SPRAY JAPAN
• Type of Device: BANDAGE, LIQUID, SKIN PROTECTANT
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10935613
• MDR Text Key: 219193084
• Report Number: 8043484-2020-04013
• Device Sequence Number: 1
• Product Code: NEC
• UDI-Device Identifier: 04582111180322
• UDI-Public: 4582111180322
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800872
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention