MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IODOSORB GEL 40G USA CTN 1; DRESSING, WOUND, DRUG

Model Number	6602125040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the clinic has been using iodosorb on patients in the past and have not had issues.As of recently, patients are complaining about iodosorb burning or stinging and is unbearable.Clinic is having to numb patients in order to use or just not use the product at all.
Additional Manufacturer Narrative
H3, h6: the device that 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 a reaction from the iodosorb ointment include pain, irritation, redness eczema, edema and allergy.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found no 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.

• Brand Name: IODOSORB GEL 40G USA CTN 1
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10856868
• Report Number: 8043484-2020-03888
• Device Sequence Number: 910121
• Product Code: FRO
• UDI-Device Identifier: 00040565122496
• UDI-Public: 00040565122496
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K190730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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: 6602125040
• Device Catalogue Number: 6602125040
• Device Lot Number: BDE272
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 06/30/2021
• 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: Other