MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07,08 report with the FDA on 1996-10-29 for RITE AID DELUXE COMBINATION SYRINGE 2673-02 manufactured by Ross Products Div., Abbott Laboratories.
[24718]
Pt was using the device when the syringe pipe broke off and became lodged in the rectum. The pt was transported to the hosp for removal. The pt was x-rayed to locate the pipe. It was removed nonsurgically, and the pt was sent home that day. Pt is doing fine. There was no illness, injury or medical intervention resulting from the event. One pt involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528738-1996-00018 |
| MDR Report Key | 47194 |
| Report Source | 04,07,08 |
| Date Received | 1996-10-29 |
| Date of Report | 1996-10-29 |
| Date of Event | 1996-07-04 |
| Date Mfgr Received | 1996-09-30 |
| Date Added to Maude | 1996-11-08 |
| 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 FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RITE AID DELUXE COMBINATION SYRINGE |
| Generic Name | 78 FCE KIT, ENEMA |
| Product Code | FCE |
| Date Received | 1996-10-29 |
| Model Number | 2673-02 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | GRANDFATHERED |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 47997 |
| Manufacturer | ROSS PRODUCTS DIV., ABBOTT LABORATORIES |
| Manufacturer Address | 625 CLEVELAND AVE COLUMBUS OH 43215 US |
| Baseline Brand Name | RITE AID DELUXE COMBINATION |
| Baseline Generic Name | ENEMA KIT |
| Baseline Model No | 2673-02 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | KF1 |
| Baseline Shelf Life Contained | A |
| 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 | 1996-10-29 |