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

Model Number SBT-546-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/06/2019

Event Type  Injury  

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 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.

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 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
• Type of Device: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9395795
• MDR Text Key: 168633916
• Report Number: 3005099803-2019-05771
• Device Sequence Number: 1
• Product Code: MNK
• UDI-Device Identifier: 00840253104809
• UDI-Public: 00840253104809
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SBT-546-100
• Device Catalogue Number: 60264
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other