MAUDE Adverse Event Report: PFIZER, INC. (DEVICE) ADD-VANTAGE ADDAPTOR; DEVICE DELIVERY AID; CLASS II

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2023

Event Type  malfunction  

Event Description

Event verbatim [preferred term] advantage bags are exploding/bursting under pressure (in the transit tubes or on activation) past 4 years [device breakage], , narrative: this is a spontaneous report received from a contactable reporter(s) (consumer or other non hcp).A patient (no qualifiers provided) received add-vantage adaptor (add-vantage adaptor), from 01jan2020 to 07jun2023.The patient's relevant medical history and concomitant medications were not reported.The following information was reported: device breakage (non-serious) with onset (b)(6) 2023 at 14:15, outcome "unknown", described as "advantage bags are exploding/bursting under pressure (in the transit tubes or on activation) past 4 years".Additional information: hospitalization prolonged: no.Date of start of drug: (b)(6) 2020, date of last administration: (b)(6) 2023.

Event Description

Event verbatim [preferred term] advantage bags are exploding/bursting under pressure (in the transit tubes or on activation) past 4 years [no adverse event], , narrative: this case has been considered invalid as no adverse effect was reported.This is a spontaneous report received from a contactable reporter(s) (consumer or other non hcp).A patient (no qualifiers provided) received add-vantage adaptor (add-vantage adaptor), from 01jan2020 to 07jun2023.The patient's relevant medical history and concomitant medications were not reported.The following information was reported: no adverse event (non-serious) with onset 07jun2023 at 14:15, outcome "unknown", described as "advantage bags are exploding/bursting under pressure (in the transit tubes or on activation) past 4 years".Additional information: hospitalization prolonged: no.Date of start of drug: 01jan2020, date of last administration: 07jun2023.Product quality group provided investigational results for add-vantage adaptor: there is no root cause identified during this investigation.After one last re-review, it was determined that we could not rule out the adaptor as contributory to the event, so this is still device related, however instead of reportable malfunction as originally assessed, it will be made not reportable.Follow-up (07jul2023): follow-up attempts are completed.No further information is expected.Follow-up (24aug2023, 25aug2023 and 26aug2023):this is a follow-up report from product quality group.Updated information included: added the investigation results, update the assessment from reportable to not reportable, case updated to invalid.Follow-up attempts are completed.No further information is expected.

• Brand Name: ADD-VANTAGE ADDAPTOR
• Type of Device: DEVICE DELIVERY AID; CLASS II
• Manufacturer (Section D): PFIZER, INC. (DEVICE); 7000 portage road; kalamazoo MI 49001
• Manufacturer (Section G): PFIZER, INC. (DEVICE); 7000 portage road; kalamazoo MI 49001
• Manufacturer Contact: stella pietrafesa ; 66 hudson boulevard east; new york, NY 10001
• MDR Report Key: 17218505
• MDR Text Key: 318049493
• Report Number: 1810189-2023-00223
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1