MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 9.5X8.5CM CTN 20; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66000709

Device Problem Nonstandard Device (1420)

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

Event Date 03/09/2021

Event Type  Injury  

Event Description

It was reported that two of the opsite post-op dressings were used on two different wounds and they both leaked within 5 minutes of being in the shower.Dressings were not waterproof.The patient cleaned the area first, waited for the area to dry then applied the dressing.The patient waited a couple of hours before having a shower.The customer then visited a hospital and was provided with hospital grade dressings to continue tratment.

Manufacturer Narrative

H3, h6: as no lot number was provided, a review of the device history records was not possible.A complaint history review found a small number of similar instances of the reported event.There is nothing to indicate that this is outside of acceptable rates of occurrence.The device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.It was reported that when the patient entered the shower, the dressings came off.Probable root cause is incorrect application of dressings or saturation in the shower.The dressings are shower proof only and not suitable for saturation.There is also a possibility that the patient did not secure the dressings securely enough prior to showering.This combined with saturation may result in the reported event.The users of the reported product are advised to consult the ifu, to delineate future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including application and removal of dressings.As the event reported did not allege a significant non-transient harm to the patient or user, no clinical review or risk management review are required.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.

Manufacturer Narrative

A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the reported event.In addition it can be confirmed that finished product specification was satisfied at the point of release.The complaint history review confirms previous complaints of this nature with no manufacturing problems observed.A documentation review confirms no historical escalations or manufacturing problems were observed.The customer feed back form was reviewed.However, the information provided is insufficient to determine whether the patient¿s outcomes are due to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.Since it was reported the patient went to a hospital and was provided with hospital grade dressings to continue treatment, the impact to the patient beyond that which has already been reported cannot be confirmed or concluded.Therefore, no further clinical/medical assessment is warranted at this time.The risk files mitigate the reported issue with no updates required.The device was not returned for evaluation.The complaint is not confirmed.Potential factors that can contribute to the reported event include the dressings incorrectly applied or there is anything preventing the dressings from being attached directly to the skin area.This investigation is now complete, with no manufacturing problems observed, no corrective actions are deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE POST OP 9.5X8.5CM CTN 20
• Type of Device: 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN ; 5123913905
• MDR Report Key: 11617710
• MDR Text Key: 243894413
• Report Number: 8043484-2021-00768
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66000709
• Device Lot Number: 205241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 09/22/2021; 12/13/2021; 05/03/2022
• Supplement Dates FDA Received: 09/23/2021; 12/20/2021; 05/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1