SMITH & NEPHEW MEDICAL LTD. SKIN-PREP WIPES BOX 50 01; BANDAGE, LIQUID, SKIN PROTECTANT
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Catalog Number 420400 |
Device Problems
Nonstandard Device (1420); Patient Device Interaction Problem (4001)
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Patient Problems
Erythema (1840); Local Reaction (2035); Skin Tears (2516)
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Event Date 06/03/2021 |
Event Type
Injury
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Event Description
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It was reported that, after insulin pump therapy, the patient started experiencing redness and skin stripping about a couple of months ago.Patient uses skin-prep wipes to prepare for cannulation site and iv3000 1 hand 6x7cm to fixate the catheter and protect insertion site, so this adverse event could have been caused by either.Patient, who has been using our products for about 20 years, also claims that quality of such products has decreased recently, so they are not fulfilling their function to protect skin as they should.It is unknown how the patient has been alleviating/treating the injured skin.
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Manufacturer Narrative
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Additional information: d4.H3, h6: the device was used in treatment was not returned for evaluation, with all information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable root cause may include patient sensitivity to product.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found further instances of the reported event.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.Instructions for use contains recommendations and precautionary statements for proper use of product.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.
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Manufacturer Narrative
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H3, h6.The device was received and evaluated, the evaluation did not identify faults with this product nor any manufacturing related issues.A medical review was performed.The information provided is insufficient to determine whether the patient¿s symptoms, signs or outcome are due to a pre-existing or concurrent medical or surgical condition or procedure, or to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.A thorough medical assessment cannot be rendered at this time.Per case details the patient has improved since changing to the no sting products, no further harm is anticipated.A documentation review was conducted.Historical review has revealed a small number of cases recorded, with no open or closed corrective actions.The manufacturing batch records reveal no contributory factors nor insight regarding the reported event.The records detail that the product met all specifications prior to release.The sequence of events described in this complaint are not contained in the relevant risk files.There is insufficient information within the complaint description and further information included in this complaint to provide a causal link between events and the product therefore no update to the risk files is warranted.This complaint cannot be confirmed, as no further supporting documentation was provided.The instruction for use delineates the event, advising to discontinue use if redness or discomfort is experienced.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends.
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Search Alerts/Recalls
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