MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-05-03 for GOOD HEALTH COMBINATION WATER BOTTLE UNK manufactured by Faultless Rubber Co..
[56620]
The tip of the enema syringe disconnected from the syringe and remained in the rectum of the consumer. The user sustained extreme pain and required emergency room care and treatment in order to remove the device component. No sequelae were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1520456-1997-00004 |
| MDR Report Key | 89148 |
| Report Source | 04 |
| Date Received | 1997-05-03 |
| Date of Report | 1997-04-01 |
| Date of Event | 1997-02-23 |
| Date Facility Aware | 1997-02-23 |
| Report Date | 1997-04-01 |
| Date Mfgr Received | 1997-04-01 |
| Date Added to Maude | 1997-05-08 |
| 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 |
| 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 | GOOD HEALTH COMBINATION WATER BOTTLE |
| Generic Name | ENEMA SYRINGE |
| Product Code | FPF |
| Date Received | 1997-05-03 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 88142 |
| Manufacturer | FAULTLESS RUBBER CO. |
| Manufacturer Address | 268 EAST FOURTH ST. ASHLAND OH 44805 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-05-03 |