MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-02-24 for ALWAYS DISCREET PAD, ABSORBENCY/LENGTH UNKNOWN manufactured by Procter & Gamble, Inc..
[5519585]
Allergic reaction [hypersensitivity], breathing difficult, shortness of breath, could not breathe [dyspnoea], wheezing, coughing, soreness-vagina [vulvovaginal pain], feeling weak [asthenia]. A (b)(6) female consumer used always discreet pad, absorbency/length unk, 1 pad every three hours beginning (b)(6) 2015 and within a couple of hours on saturday, (b)(6) 2015, she experienced coughing, shortness of breath, wheezing and vaginal soreness. By (b)(6) morning, (b)(6) 2015, she could not breathe at all. She visited the emergency room on (b)(6) 2015, and she visited the clinic on (b)(6) 2015, as her symptoms returned. On (b)(6), she stopped using the product. Another emergency room visit occurred today on (b)(6) 2015 as the scent of the pads made her wheeze and experience breathing problems leaving her feeling weak as she opened the always discreet package while she was gathering up the pads to discard. She then knew that she was allergic to the pads. Treatment consisted of intravenous (iv) medication one time; she was given steroids and nebulizer treatments. Relevant medical history: allergy to latex. The case outcome was not recovered/not resolved. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[12934152]
Product and lot number ot provided by the reporter because the product was discarded into the trash outside her home; the consumer could not retrieve the product from the outside trash due to recurrence of symptoms with each exposure to the product, therefore, unable to proceed with product investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022168-2015-00001 |
| MDR Report Key | 4549189 |
| Report Source | 04 |
| Date Received | 2015-02-24 |
| Date of Report | 2015-02-12 |
| Date of Event | 2015-02-07 |
| Date Mfgr Received | 2015-12-12 |
| Date Added to Maude | 2015-04-09 |
| 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 CTR HILL AVE WINTON HILL BUSINESS CTR |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | PROCTER & GAMBLE, INC. |
| Manufacturer Street | 355 UNIVERSITY AVE. |
| Manufacturer City | BELLEVILLE, ONTARIO K8N5E9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K8N5E9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALWAYS DISCREET PAD, ABSORBENCY/LENGTH UNKNOWN |
| Generic Name | NONE |
| Product Code | HHD |
| Date Received | 2015-02-24 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE, INC. |
| Manufacturer Address | BELLEVILLE, ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-02-24 |