MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLOX; ENDOSCOPIC BITE BLOCK

Model Number	SBT-546-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The lot number is not known per the complainant; therefore, the device manufacture and expiration dates cannot be determined.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, the patient had an allergic reaction to the elastic of the bite blox.Reportedly, the patient appears to have pre-existing allergies to either polyester or poly urethane.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Block b5 was updated.Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block d4 and h4: the lot number is not known per the complainant; therefore, the device manufacture and expiration dates cannot be determined.Block h6: problem code 1907 captures the reportable event of allergic reaction.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned." block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a bite blox was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, the patient had an allergic reaction to the elastic of the bite blox.Reportedly, the patient appears to have pre-existing allergies to either polyester or poly urethane.The patient's condition at the conclusion of the procedure was reported to be fine.***additional information as of 26dec2019*** the allergic reaction was like a rash around the areas where the bite blox came into contact with the skin.

• Brand Name: BLOX
• Common Device Name: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9395795
• Report Number: 3005099803-2019-05771
• Device Sequence Number: 16568859
• Product Code: MNK
• UDI-Device Identifier: 00840253104809
• UDI-Public: 00840253104809
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: SBT-546-100
• Device Catalogue Number: 60264
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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