MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2002-02-19 for UNSPECIFIED ENEMA SYRINGE UNK manufactured by Abbott Laboratories.
[15713407]
Received report of a split enema pipe. It was reported that a consumer was using an enema pipe in the consumer's nostril for flushing purposes. The pipe split and an unspecified amount of bleeding occurred. The consumer realizes the they were not using the product as it was intended. However, the consumer said the procedure works best for them and the consumer will continue to use the enema pipe in this manner.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-2002-00001 |
| MDR Report Key | 377428 |
| Report Source | 04,07 |
| Date Received | 2002-02-19 |
| Date of Report | 2002-01-29 |
| Date of Event | 2002-01-01 |
| Date Mfgr Received | 2002-01-29 |
| Date Added to Maude | 2002-02-21 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | FRANK POKROP, ASSOC. DIRECTOR |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 37K BLDG J-45 |
| Manufacturer City | ABBOTT PARK IL 600646132 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646132 |
| Manufacturer Phone | 8479378473 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNSPECIFIED ENEMA SYRINGE |
| Generic Name | ENEMA SYRINGE |
| Product Code | FCE |
| Date Received | 2002-02-19 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 366512 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 268 EAST FOURTH ST. ASHLAND OH 44805 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-02-19 |