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 2015-12-23 for SMARTPILL CAPSULE FGS-0503 manufactured by Given Imaging Ltd.
[34289681]
(b)(4) initial report date: 12/23/2015. 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
[34289682]
Physician reported patient with retained smartpill capsule. Patient ingested the capsule on (b)(6) 2015 and was hospitalized (b)(6) 2015 after experiencing severe abdominal pains for 1-2 days. Xray and ct scan confirmed capsule retained in small bowel proximal to a stricture. Patient was not known to have a stricture prior to the procedure. Patient underwent surgery to remove the capsule and the stricture. Physician reported a distal ileal pelvic adhesion from a previous radiation surgery which may have caused the stricture. Patient is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2015-00327 |
| MDR Report Key | 5324970 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-12-23 |
| Date of Report | 2015-12-02 |
| Date of Event | 2015-11-23 |
| Date Mfgr Received | 2015-12-02 |
| Device Manufacturer Date | 2015-07-07 |
| Date Added to Maude | 2015-12-23 |
| 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 IMAGING LTD |
| Manufacturer Street | 2 HACARMEL ST. P.O. BOX 258 |
| Manufacturer City | NEW INDUSTRIAL PARK, YOQNEAM 20692 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 20692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTPILL CAPSULE |
| Generic Name | GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE |
| Product Code | NYV |
| Date Received | 2015-12-23 |
| Model Number | FGS-0503 |
| Catalog Number | FGS-0503 |
| Lot Number | 28851P |
| Device Expiration Date | 2017-01-15 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LTD |
| Manufacturer Address | 2 HACARMEL ST. P.O. BOX 258 NEW INDUSTRIAL PARK, YOQNEAM 20692 IS 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-23 |