MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-03-24 for GH RECTAL SYRINGE 02843 manufactured by Hospira, Inc..
[22181397]
The consumer reported that the white pipe applicator broke. While the consumer was assebling the rectal syringe for use, the white pipe applicator broke and was reportedly, "stuck in the black stopper". There were no reported adverse effects. No med interventions were required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-2006-00004 |
| MDR Report Key | 693391 |
| Report Source | 04 |
| Date Received | 2006-03-24 |
| Date of Report | 2006-02-28 |
| Date of Event | 2006-02-01 |
| Date Mfgr Received | 2006-02-28 |
| Device Manufacturer Date | 1996-03-01 |
| Date Added to Maude | 2006-03-31 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN COX, DIR. |
| Manufacturer Street | 8401 W 102ND ST, BLDG NO. HW1 DEPT. NO.097U, STE 300 |
| 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 | GH RECTAL SYRINGE |
| Generic Name | ENEMA KIT |
| Product Code | FCE |
| Date Received | 2006-03-24 |
| Returned To Mfg | 2006-03-22 |
| Model Number | NA |
| Catalog Number | 02843 |
| Lot Number | 15108ED |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 682519 |
| Manufacturer | HOSPIRA, INC. |
| Manufacturer Address | 268 EAST FOURTH ST. ASHLAND OH 44805 US |
| Baseline Brand Name | GH RECTAL SYRINGE |
| Baseline Generic Name | ENEMA KIT |
| Baseline Model No | NA |
| Baseline Catalog No | 02843 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-03-24 |