MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-05-18 for ENEMA ADM UNIT -BAG /SOAP/PAD 6010G manufactured by Cardinal Health.
[1403049]
Rectal perforation followed with liquid extravasation peritoneal of the pt. Probe tip could have been defective causing the perforation.
Patient Sequence No: 1, Text Type: D, B5
[8658411]
No sample was received for eval; therefore, we are unable to confirm the issue reported. The pvc tubing is designed and validated for pt use. The current rigidity of pvc tubing and shape, facilitates the enema administration under supervision of medical staff. The device master record and device history records for the lots reported indicate that the complete mfg processes and inspections showed no issues. The equipment, processes and parts used in the mfr of this product were verified and conform to the product specifications. Based on the info that has been reviewed there is no indication of any product failure, therefore, no corrective action will be taken at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2010-00027 |
| MDR Report Key | 1702431 |
| Report Source | 07 |
| Date Received | 2010-05-18 |
| Date of Report | 2010-05-17 |
| Date of Event | 2010-03-16 |
| Date Mfgr Received | 2010-03-29 |
| Date Added to Maude | 2010-06-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CARDINAL HEALTH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENEMA ADM UNIT -BAG /SOAP/PAD |
| Generic Name | ENEMA ADM UNIT -BAG /SOAP/PAD |
| Product Code | FCE |
| Date Received | 2010-05-18 |
| Model Number | 6010G |
| Catalog Number | 6010G |
| Lot Number | 0100545 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention | 2010-05-18 |