MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-03-25 for CYTO-KIT-R CYTO-KITR manufactured by Medtronic.
[41210335]
The sample has been requested but to date the incident sample 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.
Patient Sequence No: 1, Text Type: N, H10
[41210336]
Physician reported patient experiencing substernal burning sensation after undergoing a cytosponge procedure. Patient stated that the symptoms started after egd. Burning was not worse with eating, just there at times. The burning was not worse with exertion and she denied nausea, vomiting, dysphagia, and odynophagia. She rated the burning sensation 7 on a scale of 0-10. Physician prescribed omeprazole for the pain. On (b)(6) 2016 the gi physician ordered a chest x-ray that was normal. On (b)(6) 2016: patient present in ed at (b)(6) for palpitations (ekg + lab = normal). Pt discharged same day without admission (b)(6) 2016: patient present in ed at (b)(6) with nausea and vomiting. Labs were normal. Given acetaminophen and anti-emetics and discharged home on the same day. Patient is feeling better now and is still on omeprazole. Patient denies any associated symptoms and just feels a little soreness (substernal). Physician for regular follow-up on (b)(6) 2016. (see attached email) this form has a status of incomplete. (b)(6). (b)(6) 2016: email from site coordinator, (b)(6), states, patient seen by gi physician. Patient denied any significant symptoms. Intermittently she would have some heartburn but overall controlled with ppi. She has been on prilosec as needed for the heartburn. ; (see attachment) on rdc: the subject was started on ppi therapy. Symptoms had much improved on the treatment. One month after the follow-up phone call, the patient denied any significant symptoms. ; (see attachment) (b)(6) 2016: ae resolved. Per physician: relationship to device: possible; relationship to endoscopy procedure: possible; ae classification: moderate; unanticipated adverse device effect (uade): no action taken: medication this form has a status of complete.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004904811-2016-00024 |
| MDR Report Key | 5527577 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-03-25 |
| Date of Report | 2016-02-25 |
| Date of Event | 2016-01-15 |
| Date Mfgr Received | 2016-02-25 |
| Date Added to Maude | 2016-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 540 OAKMEAD PARKWAY |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | MEDTRONIC |
| Manufacturer Street | 540 OAKMEAD PARKWAY |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYTO-KIT-R |
| Generic Name | ESOPHAGOSCOPE |
| Product Code | EOX |
| Date Received | 2016-03-25 |
| Model Number | CYTO-KITR |
| Catalog Number | CYTO-KITR |
| Lot Number | F2500202X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | 540 OAKMEAD PARKWAY SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-25 |