MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2000-06-15 for WALGREEN COMBINATION 02091 manufactured by Abbott Laboratories.
[171178]
Report received from a consumer that the enema tip and adapter came off during use and was lodged inside the rectum. Additional info was requested and a letter was received that verified the enema tip came off of the tubing internally and was lodged. The consumer could not manually remove the product initially. Consumer phoned a hosp emergency dept and was told that the product would have to be removed manually by a physician or may require surgery if the product "went past the colon". The consumer can only work with naturopathic physicians and energy healing centers and is "unable to take any type of medications because consumer's body is allergic to them". Consumer did not go to the emergency room. Consumer went to bed that night and "woke up at 6am with pain in stomach and with much gas build-up. " by 6:30 am consumer was able to manually remove the product. Consumer is "still experiencing pain in the stomach area". Consumer continues to "work with natural doctors to help the healing process". No additional info was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-2000-00004 |
| MDR Report Key | 282367 |
| Report Source | 04 |
| Date Received | 2000-06-15 |
| Date of Report | 2000-05-16 |
| Date of Event | 2000-05-01 |
| Date Mfgr Received | 2000-05-16 |
| Date Added to Maude | 2000-06-21 |
| 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 | JILL SACKETT DIRECTOR |
| Manufacturer Street | 200 ABBOTT PARK RD. |
| Manufacturer City | ABBOTT PARK IL 600646157 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646157 |
| Manufacturer Phone | 8479374085 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALGREEN COMBINATION |
| Generic Name | HOT WATER BOTTLE |
| Product Code | FPF |
| Date Received | 2000-06-15 |
| Model Number | NA |
| Catalog Number | 02091 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 273253 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 268 EAST FOURTH ST. ASHLAND OH 44805 US |
| Baseline Brand Name | WALGREEN COMBINATION |
| Baseline Generic Name | HOT WATER BOTTLE |
| Baseline Model No | NA |
| Baseline Catalog No | 02091 |
| Baseline Device Family | BOTTLE, HOT/COLD WATER |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-06-15 |