MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-04-15 for ALWAYSLNR manufactured by Procter & Gamble Inc.
[42772835]
Return of product has been requested. Product and lot number not provided by reporter therefore unable to proceed with product investigation at this time. Full evaluation will occur upon receipt of returned product.
Patient Sequence No: 1, Text Type: N, H10
[42772836]
Voice closed up due to fragrance [throat tightness] allergy/allergic reaction [hypersensitivity] lips swollen due to fragrance [lip swelling] rash on hands due to fragrance [rash] sore throat due to fragrance [oropharyngeal pain] eyes tearing due to fragrance [lacrimation increased] inhaled liner fragrance [exposure via inhalation]. Case description: a (b)(6) female consumer used an always liner, one liner with perfume, once only for the first time six months ago on an unspecified date in (b)(6) 2015 and the product caused her to have an allergy. The consumer reported her voice closed up, her lips were swollen, her eyes were weeping, her throat was sore, and she developed a rash on her hands beginning on an unspecified date in (b)(6) 2015. She visited the hospital where she received intravenous therapy for a few hours. Additional treatment included "testin" pills and zyrtec. Product use was discontinued. Her symptoms completely resolved after five days. The case outcome was recovered. Relevant history: allergies to perfumes, flowers, walnuts, and hazelnuts. Concomitant product(s): none reported. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022168-2016-00001 |
| MDR Report Key | 5580564 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-04-15 |
| Date of Report | 2016-03-16 |
| Date Mfgr Received | 2016-03-16 |
| Date Added to Maude | 2016-04-15 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MGR. REGULATORY FEMININE CARE |
| Manufacturer Street | 6110 CENTER HILL AVENUE |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | PROCTER & GAMBLE INC |
| Manufacturer Street | 365 UNIVERSITY AVE |
| Manufacturer City | BELLEVILLE, ON K8N5E9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K8N5E9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALWAYSLNR |
| Generic Name | PAD, MENSTRUAL, SCENTED |
| Product Code | HHL |
| Date Received | 2016-04-15 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE INC |
| Manufacturer Address | 365 UNIVERSITY AVE BELLEVILLE, ON K8N5E9 CA K8N5E9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-15 |