MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2003-03-11 for WALGREENS PERSONAL DOUCHE & ENEMA SYSTEM 02123 manufactured by Abbott Laboratories.
[21248846]
Rectal lacerations due to a sharp edge on the plastic tubing of a personal douche and enema system. The pt purchased the device for home use. After using the product, they discovered there was a sharp edge on the plastic tubing, causing lacerations to their rectal area. The pt sought unspecified medical attention and treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-2003-00001 |
| MDR Report Key | 448176 |
| Report Source | 04 |
| Date Received | 2003-03-11 |
| Date of Report | 2003-02-10 |
| Date of Event | 2003-01-26 |
| Date Mfgr Received | 2003-02-10 |
| Date Added to Maude | 2003-03-18 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS SAMPOGNA, ASSOC. DIR. |
| Manufacturer Street | 200 ABBOTT PARK RD DEPT. 389 BLDG. J-45 |
| Manufacturer City | ABBOTT PARK IL 600646132 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646132 |
| Manufacturer Phone | 8479353715 |
| 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 | WALGREENS PERSONAL DOUCHE & ENEMA SYSTEM |
| Generic Name | COMBINATION DOUCHE/ENEMA SYSTEM |
| Product Code | FCE |
| Date Received | 2003-03-11 |
| Model Number | NA |
| Catalog Number | 02123 |
| 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 | 437160 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 268 EAST FOURTH ST. ASHLAND OH 44805 US |
| Baseline Brand Name | WALGREENS PERSONAL DOUCHE & ENEMA SYSTEM |
| Baseline Generic Name | ENEMA KIT |
| Baseline Model No | NA |
| Baseline Catalog No | 02123 |
| Baseline ID | NA |
| Baseline Device Family | KIT, ENEMA, FOR CLEANING PURPOSE |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-03-11 |