MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2013-11-08 for ALWAYS/ALLDAYS PANTYLINER, SCENTED manufactured by Procter & Gamble Gmbh & Co..
[18621052]
Breathing difficult [dyspnoea]. Asthma attack [asthma]. (asthma) got worse [condition aggravated]. Case description: a consumer reported that they, a female age (b)(6) years, used always long plus pantyliners with actipearls, liner at a time for a few hours each and reported that the perfume from the liners caused an asthma attack and difficulty breathing. The consumer explained she noticed a strong smell in the bathroom but did not know the product was scented and could not find the info on the package regarding the stent until after her asthma attack. The asthma attack started when she opened the package of liners. The consumer reported she already had asthma, but the use of this product made her condition worse. The consumer used the instant treatment inhaler that she was already prescribed, but her condition did not improve. The consumer was hospitalized for 2 days and given stronger versions of the medications she normally takes. The treatment included: ventoline, oxis and alvesco. The case outcome was recovered. The consumer stated that it was not just the perfume in the liner that caused her to say overnight in the hospital "but it was a big part of it". Past medical history included: seasonal and food allergies and a bad case of asthma. Previous exposure history included: used the unscented version of the product before. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[18766611]
Product was not returned to the company by the consumer and no valid lot number was provided, therefore unable to complete product investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680085-2013-00002 |
| MDR Report Key | 3480791 |
| Report Source | 01,04 |
| Date Received | 2013-11-08 |
| Date of Report | 2013-09-19 |
| Date Mfgr Received | 2013-09-19 |
| Date Added to Maude | 2013-11-22 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 6110 CENTER HILL AVE WINTON HILL BUSINESS CTR |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | PROCTER & GAMBLE GMBH & CO. |
| Manufacturer Street | MANUFACTURING DHE, P&G STRASSE 1 |
| Manufacturer City | CRAILSHEIM 74564 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 74564 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALWAYS/ALLDAYS PANTYLINER, SCENTED |
| Generic Name | NONE |
| Product Code | HHL |
| Date Received | 2013-11-08 |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE GMBH & CO. |
| Manufacturer Address | CRAILSHEIM GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2013-11-08 |