MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 1998-09-14 for VOLUMATIC K844169 * manufactured by Courtaulds Packaging.
[104010]
Pharmacist initially reported that female pt with history of mitral valve prolapse, pancreatic damage, hiatus hernia and stomach ulcers received inhaled beclomethasone dipropionate (becotide) 100mcg (bdp). Pt herself reported that she had used bdp for 5 yrs, but had recently started using volumatic spacer device further to diagnosis of candidiasis of the throat for which she was also receiving nystatin. Each of three times she used spacer, she developed sharp chest pains, sweating and had difficulty breathing in through spacer. Symptoms lasted about 20 minutes and she dealt with symptoms by sitting quietly events were reported initially by pharmacist as resembling heart attack occurring one hr after use of inhaler plus spacer and lasting three hrs. Although pharmacist reported pt had been hospitalised (and that events were life-threatening), pt confirmed she had not been hospitalized. Pt said she does not experience events when she does not use spacer however, pains recur when she does use spacer. Info was also received via therapeutic good agency who reported event as incident that was associated with use of volumatic. Pt was noted to have had difficulty breathing during events, and that she needed to 'breath extra-hard to get required medication - difficult to use'. Without volumatic, few chest pains were experienced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1033964-1998-00001 |
| MDR Report Key | 187444 |
| Report Source | 01,05 |
| Date Received | 1998-09-14 |
| Date of Report | 1998-09-11 |
| Date Mfgr Received | 1998-08-14 |
| Date Added to Maude | 1998-09-17 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOLUMATIC |
| Generic Name | AEROSOL EXPANSION CHAMBER DEVICE FOR METERED-DOSE INHALERS |
| Product Code | BYP |
| Date Received | 1998-09-14 |
| Model Number | K844169 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | XY0076100 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 182194 |
| Manufacturer | COURTAULDS PACKAGING |
| Manufacturer Address | 505 IPSWICH RD COLCHESTER, ESSEX ENGLAND UK C044HE |
| Baseline Brand Name | VOLUMATIC |
| Baseline Generic Name | AEROSOL EXPANSION CHAMBER FOR MDI |
| Baseline Model No | K844169 |
| Baseline Catalog No | * |
| Baseline ID | XY0076100 |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 6 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1998-09-14 |