MAUDE Adverse Event Report: COVIDIEN 1806 SPG GZ 2X2 8 PLY STERILE; FIBER, MEDICAL, ABSORBENT

Model Number	1806
Medical Device Problem Codes	Material Discolored (1170); Problem with Sterilization (1596)
Health Effect - Clinical Codes	Inflammation (1932); Local Reaction (2035)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer stated that it looks as if the gauze pad is burnt causing him to have a reaction.The customer further stated that he went to the er for a tooth extraction.The doctor gave him a gauze pad to help stop the bleeding and he put the gauze pad in his mouth for two hours and noticed a strange taste.The customer further stated that the area where the gauze was placed has turned black, he experienced swelling, and lost 30 lbs.Antibiotics were prescribed.
Additional Manufacturer Narrative
There was no sample provided for investigation.A photo was provided by customer and was reviewed by the supplier; the photo only showed the pouch printing with a lot number for tracking; therefore the supplier still cannot identify the problem.The supplier checked the toxicity of the complained products, the complained sku1806 is gauze product and sterile by eo, they had finished biocompatibility/ toxicity evaluation/testing for finished eo sterilized gauze products according to standard iso 10993-1.The results show no potential toxicity.They checked the toxicity of the complained product's package, the complained sku1806 is packed in paper-paper pouch and sterile by eo, they have cytotoxicity evaluation/testing for eo sterile paper-paper pouch according to standard iso 10993-5, the results show no potential toxicity.Furthermore, the function of the gauze product is to absorb the bloods / exudates and has no function to stop bleeding.Based on the investigation, both the eo sterile gauze products and primary sterile package (paper pouch) shows no potential toxicity, and the function of the gauze product is to absorb the bloods / exudates, has no function to stop bleeding, therefor a root cause cannot be identified as the product is functioning as it is intended for use.The complaint information was informed to the relevant sectors for their awareness and will continue to monitor the trend of this type of incident.

• Brand Name: 1806 SPG GZ 2X2 8 PLY STERILE
• Common Device Name: FIBER, MEDICAL, ABSORBENT
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11784948
• Report Number: 1282497-2021-10155
• Device Sequence Number: 3909411
• Product Code: FRL
• UDI-Device Identifier: 10884521058576
• UDI-Public: 10884521058576
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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: No Information
• Device Model Number: 1806
• Device Catalogue Number: 1806
• Device Lot Number: D20081032S
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 07/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other