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 2015-11-17 for P/CAM PATENCY CAPL 1-PK FGS-0109 manufactured by Given Ltd (israel).
[31431440]
(b)(4) initial report date: 11/17/2015. 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
[31431441]
Customer reported patient experiencing abdominal pain after taking patency capsule. Physician is not certain if the capsule has passed. Physician plans to conduct a ct scan to determine if the patency capsule is residing in the descending colon. Previous ct scans were normal showing no strictures. This is being reported out of an abundance of caution.
Patient Sequence No: 1, Text Type: D, B5
[36867501]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710107-2015-05036 |
| MDR Report Key | 5230969 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-11-17 |
| Date of Report | 2015-10-19 |
| Date Mfgr Received | 2015-10-19 |
| Date Added to Maude | 2015-11-17 |
| 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 | GIVEN LTD (ISRAEL) |
| Manufacturer Street | 2 HACARMEL ST. NEW INDUSTRIAL POB 258, |
| Manufacturer City | YOQNEAM |
| Manufacturer Country | IS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | P/CAM PATENCY CAPL 1-PK |
| Generic Name | SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE |
| Product Code | NSI |
| Date Received | 2015-11-17 |
| Model Number | FGS-0109 |
| Catalog Number | FGS-0109 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN LTD (ISRAEL) |
| Manufacturer Address | 2 HACARMEL ST. NEW INDUSTRIAL POB 258, YOQNEAM IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-17 |