MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-07-06 for MEDLINE * DYND 70100 manufactured by Medline Industries, Inc..
[17822680]
Pt presents with elective colonoscopy. Cleansing enema given prior to procedure. Internal linear abrasions noted in rectum. Pt complained of post enema rectal pain. Physician postoperative finding "enema tip trauma".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019243 |
| MDR Report Key | 284925 |
| Date Received | 2000-07-06 |
| Date of Report | 2000-06-23 |
| Date of Event | 2000-06-21 |
| Date Added to Maude | 2000-07-11 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLINE |
| Generic Name | CLEANSING ENEMA SET |
| Product Code | FCE |
| Date Received | 2000-07-06 |
| Model Number | * |
| Catalog Number | DYND 70100 |
| Lot Number | 0E3013 & 0D3071 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 275729 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PL. MUNDELEIN IL 600604486 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-07-06 |