MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2013-06-18 for ALWAYS/ALLDAYS PANTYLINER, SCENTED manufactured by Procter & Gamble Gmbh & Co..
[3516859]
Allergic reaction [hypersensitivity]. Swollen [oedema]. Puffiness face [swelling face]. Couldn't breathe/short of breath [dyspnoea]. Case description: a consumer reported that they, a female age unspecified, used always/alldays pantyliner, scented liner total of four liners over a day and a half beginning (b)(6) 2013 and reported the following: had an allergic reaction when she woke up (b)(6) 2013 swollen; face puffiness and could not breathe. The consumer visited her physician and received four cortizone shots. The case outcome was improved. Past medical history included: medical history - unspecified allergies, asthma. Concomitant medications included: allergy medication. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680085-2013-00001 |
| MDR Report Key | 3185676 |
| Report Source | 01,04 |
| Date Received | 2013-06-18 |
| Date of Report | 2013-05-27 |
| Date Mfgr Received | 2013-05-27 |
| Date Added to Maude | 2013-06-26 |
| 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 | 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. MANUFACTURING OHE |
| Manufacturer Street | 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 | 2013-06-18 |
| Device Eval'ed by Mfgr | * |
| 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. Other | 2013-06-18 |