MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-06 for RECTAL SYRINGE UNK manufactured by Apothecary Products Inc..
[73186]
Rptr was using the product on her grandson, when he complained of extreme pain. To investigate, rptr used the syringe on herself and experienced the pain also. When rptr felt the tip of the syringe, it was sharp and rough. This can only be felt and not seen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012741 |
| MDR Report Key | 141765 |
| Date Received | 1998-01-06 |
| Date of Report | 1998-01-06 |
| Date of Event | 1997-12-13 |
| Date Added to Maude | 1998-01-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RECTAL SYRINGE |
| Generic Name | 102 RECTAL SYRINGE FOR ENEMA |
| Product Code | FCE |
| Date Received | 1998-01-06 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 2571566763-BAR CODE |
| ID Number | STOCK # 66763 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 138309 |
| Manufacturer | APOTHECARY PRODUCTS INC. |
| Manufacturer Address | 11531 RUPP DR. BURNSVILLE MN 55337 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-01-06 |