MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-06-04 for ENEMA BAG 145540 manufactured by Covidien.
[17836105]
It was reported to covidien on (b)(6) 2013 that a customer had an issue with an enema bag. The customer reports the nurse accidentally did not take off the blue cap on the tap water enema and the blue piece ended up being lodged in the patients colon. The facility stated the patient underwent a flexible sigmoidoscopy (flex sig) procedure to remove the blue piece. The patient is stated as stable and has been discharged.
Patient Sequence No: 1, Text Type: D, B5
[18055063]
Submit date on: 06/03/2013. An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2013-00017 |
| MDR Report Key | 3159312 |
| Report Source | 06,07 |
| Date Received | 2013-06-04 |
| Date of Report | 2013-05-21 |
| Date of Event | 2013-05-19 |
| Date Facility Aware | 2013-05-19 |
| Report Date | 2013-05-21 |
| Date Reported to Mfgr | 2013-05-21 |
| Date Mfgr Received | 2013-05-21 |
| Date Added to Maude | 2013-06-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | SHARON SELBY |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618488 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA 92173 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENEMA BAG |
| Generic Name | ENEMA |
| Product Code | FCE |
| Date Received | 2013-06-04 |
| Model Number | 145540 |
| Catalog Number | 145540 |
| Lot Number | 305654064X |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-06-04 |