MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-07-14 for WALGREEN'S DOUCHE SYSTEM - BULB STYLE 02157 manufactured by Hospira, Inc..
[489480]
A "sharp edge" on the douche pipe; subsequently a "scratch" occurred and blood loss was noted. The consumer filled the bulb syringe with water, administered the douche which reportedly "hurt just a little bit. " after the douche pipe was removed, "quite a bit of blood" was noted. The amount of blood was unspecified. During examination of the device, it was noted there was "a sharp edge from the tip all the way to the bottom of the pipe. " the physician was contacted and during examination a "scratch" on the wall of the vagina was noted. During a follow-up visit with her gynecologist, she was told that she was "completely healed. " there was no reported adverse pt sequelae.
Patient Sequence No: 1, Text Type: D, B5
[7778051]
At this time, the consumer will not be returning the device for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1520456-2005-00003 |
| MDR Report Key | 742170 |
| Report Source | 04 |
| Date Received | 2005-07-14 |
| Date of Report | 2005-06-20 |
| Date of Event | 2005-05-09 |
| Date Mfgr Received | 2005-06-20 |
| Date Added to Maude | 2006-08-01 |
| 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 | PAUL LANDESMAN, PH.D., DIR |
| Manufacturer Street | 8401 WEST 102ND ST, STE 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 E FOURTH ST |
| 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'S DOUCHE SYSTEM - BULB STYLE |
| Generic Name | VAGINAL DOUCHE SYSTEM |
| Product Code | HED |
| Date Received | 2005-07-14 |
| Model Number | NA |
| Catalog Number | 02157 |
| 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 | 730006 |
| Manufacturer | HOSPIRA, INC. |
| Manufacturer Address | 268 EAST FOURTH ST. ASHLAND OH 44805 US |
| Baseline Brand Name | WALGREEN'S DOUCHE SYSTEM - BULB STYLE |
| Baseline Generic Name | VAGINAL DOUCHE SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | 02157 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-07-14 |