MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-05-12 for BAG, ENEMA, SLIDE, CLAMP, POLYBAG DYND70102 * manufactured by Medline Industries, Inc..
[371104]
While receiving a rectal contrast ct a pt's rectum was perforated. The pt went into renal failure and required a colostomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2005-00009 |
| MDR Report Key | 601928 |
| Report Source | 05,07 |
| Date Received | 2005-05-12 |
| Date of Report | 2005-05-09 |
| Date of Event | 2005-04-11 |
| Date Mfgr Received | 2005-04-11 |
| Date Added to Maude | 2005-05-16 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARGARET STEPHENS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8479492277 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAG, ENEMA, SLIDE, CLAMP, POLYBAG |
| Generic Name | ENEMA BAG |
| Product Code | FCE |
| Date Received | 2005-05-12 |
| Model Number | DYND70102 |
| Catalog Number | * |
| Lot Number | 102104AS007 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 591756 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | * MUNDELEIN IL * US |
| Baseline Brand Name | BAG, ENEMA, SLIDE CLAMP, POLYBAG |
| Baseline Model No | DYND70102 |
| Baseline Device Family | DNT2 |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-05-12 |