MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-24 for COLOCORT 7 COUNT PACKET * manufactured by Paddock Laboratories, Inc..
[302511]
This consumer has severe ulcerative colitis and has many other problems with product allergies. They were prescribed colocort enema to use everyday in the evening prior to going to bed. They did use it but instead of getting better they progressively got sick with loss of bowel control, open sores, rectal bleeding and they also suffered with heart palpitations and finally their doctor had to put them on hydrocortisone suspension plus 100 "mlg". Of prednisone by mouth everyday. They were not getting better, then they noticed that the enema applicator had a lubricant on it, and they called the manufacturing labs. And asked for info about the ingredients listed on the enema packaging, in order to find out if there was something in them that could cause a problem with their system, (they have a severe allergic reaction to 'mineral oil' since they had been ill from formaldahyde poisoning years before). The person they spoke to at paddock labs, told them that all of the ingredients in the enema are listed on the labeling (carboner 934t, polisorbate 80, purified water, sodium hydroxide, metil paraben) and that the only thing not listed on the enema kit was the applicator's lubricant (petroleum jelly). Pt said that that was the ingredient that caused them all of the problems for all of the 10 weeks they used the enema kit. Their doctor is also concerned now and is going to reevaluate their case when he gets back from a business trip, and see what he can do to help the problem. In the meantime they have been sick for all of those weeks (10 weeks) and taking strong doses of prednisone and hydrocortisone which are too strong for their very sensitive health. They feel that the 'petroleum jelly" should also be listed somewhere on the product labeling for consumers like them that have intolerance to the ingredient.
Patient Sequence No: 1, Text Type: D, B5
[309080]
Add'l info rec'd from mfr 03/31/2004. Mfr has received medical device report number mw4003594 for a "kit, enema, (for cleaning purpose)". The product involved with this report is, however, not a medical device enema kit, but rather is the drug. Hydrocortisone (100mg/60ml) enema, anda 75-172. Since the product is a drug, mfr has completed its investigation and reported results per usual procedure through the fda drug quality (medwatch) reporting system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003594 |
| MDR Report Key | 490390 |
| Date Received | 2003-09-24 |
| Date of Report | 2003-07-24 |
| Date of Event | 2002-05-01 |
| Date Added to Maude | 2003-10-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | COLOCORT |
| Generic Name | ENEMA KIT SET FOR ULCERATIVE COLITIS |
| Product Code | FCE |
| Date Received | 2003-09-24 |
| Model Number | 7 COUNT PACKET |
| Catalog Number | * |
| Lot Number | NDC#057420 20 |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 479124 |
| Manufacturer | PADDOCK LABORATORIES, INC. |
| Manufacturer Address | 3940 QUEBEC AVE NORTH MINNEAPOLIS MN 55427 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-09-24 |