MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-05-05 for WALGREEN COMBINATION 02091 manufactured by Hospira, Inc..
[15482860]
Subsequent to the initial medwatch submission the following information was received: the pt had a proctoscopy to remove the applicator. The pt was discharged in 2004 with a prescription for augumentin 500mg three times daily and an unspecified pain medication.
Patient Sequence No: 1, Text Type: D, B5
[19964810]
Report received of applicator breakage. While the consumer was administering an unspecified amount of solution rectally, the "nozzle" (applicator) either disconnected or broke. The customer was unable to remove the applicator and went to the e. R.. The pt had surgery to remove the applicator and was reporteldy hospitalized for 4 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-2005-00002 |
| MDR Report Key | 599884 |
| Report Source | 04 |
| Date Received | 2005-05-05 |
| Date of Report | 2005-04-11 |
| Date of Event | 2005-03-11 |
| Date Mfgr Received | 2005-04-11 |
| Date Added to Maude | 2005-05-10 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PAUL LADESMAN, PH.D., ASST DIR |
| Manufacturer Street | 8401 W. 102ND ST., SUITE 300 DEPT.NO.097U, BLDG.NO.HW1 |
| Manufacturer City | PLEASANT PRAIRIE WI 53158 |
| Manufacturer Country | US |
| Manufacturer Postal | 53158 |
| Manufacturer Phone | 2625776072 |
| Manufacturer G1 | HOSPIRA, INC. |
| Manufacturer Street | 268 EAST FOURTH STEET |
| Manufacturer City | ASHLAND OH 44805 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44805 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALGREEN COMBINATION |
| Generic Name | COMBINATION ENEMA KIT |
| Product Code | FPF |
| Date Received | 2005-05-05 |
| Model Number | NA |
| Catalog Number | 02091 |
| 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 | 589724 |
| Manufacturer | HOSPIRA, INC. |
| 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. Hospitalization; 2. Required No Informationntervention | 2005-05-05 |