MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-08-07 for PIE manufactured by Pie Medical International.
[2724841]
Cs complete quadraplegia male presented with a rectal perforation requiring colectomy. He did not have any known colon disease prior. He used a pie (pulsed irrigation evacuation) device every other day. The emesis and abdominal pain began more than 24 hours after using the pe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2627631 |
| MDR Report Key | 2627631 |
| Report Source | 99 |
| Date Received | 2009-08-07 |
| Date of Report | 2009-08-06 |
| Date of Event | 2009-07-14 |
| Date Facility Aware | 2009-07-14 |
| Report Date | 2009-08-06 |
| Date Added to Maude | 2012-06-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIE |
| Generic Name | STOOL EVACUATION |
| Product Code | KQT |
| Date Received | 2009-08-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PIE MEDICAL INTERNATIONAL |
| Manufacturer Address | 4809 RIVERVIEW WAY DULUTH GA 30097 US 30097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2009-08-07 |