MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-06-13 for NOT KNOWN * manufactured by Unk.
[305363]
Pt had abdominal surgery in 2002. Pt gets allergy shots every other week. Pt had an allergist appointment to renew usage of inhalers. While at the dr's office and while doing the peak flow meter. Pt felt pop 4x and a rush of gas in their abdomen. Pt has been in horrible pain ever since. Their clips may have moved. Their hernias may have repopped. The surgery doctors keep telling to the pt to go to someone else. Pt went to the the e. R. Twice. Pt feels like shrapnel is in them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028720 |
| MDR Report Key | 466758 |
| Date Received | 2003-06-13 |
| Date of Report | 2003-06-13 |
| Date of Event | 2003-04-18 |
| Date Added to Maude | 2003-06-23 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | NOT KNOWN |
| Generic Name | PEAK FLOW METER |
| Product Code | BZH |
| Date Received | 2003-06-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 455703 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2003-06-13 |