MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2015-11-18 for CYTOSPONGE CELL COLLECTION DEVICE CYTO-KITR manufactured by Medtronic.
[31525454]
(b)(4). 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[31525455]
It was reported that patient was experiencing severe pain for 3-4 days following cytosponge procedure. Patient reported difficulty eating solid food. Patient proceeded to take heartburn medication to relieve the pain. Patient reported black stool for 3 days. Pain resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004904811-2015-00030 |
| MDR Report Key | 5233549 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2015-11-18 |
| Date of Report | 2015-10-20 |
| Date of Event | 2015-10-20 |
| Date Mfgr Received | 2015-10-20 |
| Date Added to Maude | 2015-11-18 |
| 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 | CYTOSPONGE CELL COLLECTION DEVICE |
| Generic Name | ESOPHAGOSCOPE |
| Product Code | EOX |
| Date Received | 2015-11-18 |
| Model Number | CYTO-KITR |
| Catalog Number | CYTO-KITR |
| Lot Number | F2500042X |
| 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. Other | 2015-11-18 |