MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 1999-02-05 for OSCO COMBINATION 6775 manufactured by Abbott Laboratories.
[17104791]
Report received from american stores co which states "tip of enema pipe broke off when consumer was using and lodged itself internally. Consumer sought medical attention for this. " no further info is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-1999-00001 |
| MDR Report Key | 209346 |
| Report Source | 04,07 |
| Date Received | 1999-02-05 |
| Date of Report | 1999-01-08 |
| Date of Event | 1998-12-12 |
| Date Mfgr Received | 1999-01-08 |
| Date Added to Maude | 1999-02-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSCO COMBINATION |
| Generic Name | ENEMA KIT |
| Product Code | FCE |
| Date Received | 1999-02-05 |
| Returned To Mfg | 1999-03-09 |
| Model Number | NA |
| Catalog Number | 6775 |
| Lot Number | UNK |
| 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 | 203163 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 268 EAST FOURTH ST. ASHLAND OH 44805 US |
| Baseline Brand Name | OSCO COMBINATION |
| Baseline Generic Name | ENEMA KIT |
| Baseline Model No | NA |
| Baseline Catalog No | 6775 |
| Baseline ID | * |
| Baseline Device Family | KIT, ENEMA, FOR CLEANING PURPOSE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-02-05 |