MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-06-21 for ALWAYSPADSTHICKPLTMODORLOCKWING manufactured by Procter & Gamble Manfactura.
[47828274]
Product not returned by reporter. This always pad product was manufactured in (b)(4) at a plant that currently does not have an active medical device establishment number so we will be submitting this case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[47828275]
Allergic reaction [hypersensitivity]. Infection - vagina [vaginal infection]. Burning sensation - vagina [vulvovaginal burning sensation]. Pain - vagina [vulvovaginal pain]. Irritation - vagina [vulvovaginal discomfort]. Case description: a parent reported that his/her (b)(6) daughter used always pads thick platinum odor-lock wing beginning on an unspecified date for the first time, having used several pads, one at a time. The parent described that they gave his/her daughter a horrible irritation; she was in a lot of pain and had a burning sensation that began on (b)(6) 2016. The parent reported that he/she had taken his/her daughter to three gynecologists; he/she used malva baths, medifugol, and corticoid to help treat his/her daughter's symptoms. Product use was discontinued on 05-may-2015. The case outcome was not recovered/not resolved. Other relevant history: allergies - none. No further information was provided. On 13-may-2016 received follow-up phone call: the aunt was at the clinic waiting for her niece to be attended to. She stated that the infection was caused by the product. They were waiting for the doctor to attend to them, her niece was previously seen by the gynecologists. The case outcome remained not recovered/not resolved. No further information was provided. On 19-may-2016 received follow-up phone call: the mother reported that she just picked her little girl up from the clinic where she had been since (b)(6) 2016. The mother asserted that her daughter's symptoms were connected to the use of the pads. The mother described that her daughter was in the clinic because of some terrible symptoms, beginning with an allergic reaction. The mother questioned if the pads had any gel. At the time of the mother's phone call on (b)(6) 2016, her daughter was resting. She explained that her daughter had been unable to go to school for three weeks. Her daughter was taking two antibiotics aside from all of the unspecified medications they gave her daughter while she was in the clinic. The mother stated that her daughter would need to go back to the gynecologist on (b)(6) 2016 for a checkup but would continue to rest, at home; the mother asserted that she didn't want her daughter to spend so long in the clinic where she was exposed to many other things. The mother reported that they were in the emergency room of one hospital, and then her daughter was transferred to another hospital. Her daughter was then transferred to a third hospital, where the mother reported they were able to turn her daughter around. The case outcome was now improved. No further information was provided. On 31-may-2016 received follow-up phone call: the mother reported that her daughter just started college on (b)(6) 2016 as after 3 weeks, her daughter had just gotten back to school. The mother stated that the obstetrician-gynecologist had seen her daughter last week and has discharged her daughter. The case outcome was now recovered. No further information was provided. .
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003678546-2016-00001 |
| MDR Report Key | 5737991 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-06-21 |
| Date of Report | 2016-05-11 |
| Date Mfgr Received | 2016-05-19 |
| Date Added to Maude | 2016-06-21 |
| 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 MANFACTURA |
| Manufacturer Street | PARQ IND TEPEJI |
| Manufacturer City | DEL RIO, HGO 42850 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 42850 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALWAYSPADSTHICKPLTMODORLOCKWING |
| Generic Name | PAD, MENSTRUAL, SCENTED |
| Product Code | HHL |
| Date Received | 2016-06-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROCTER & GAMBLE MANFACTURA |
| Manufacturer Address | PARQ IND TEPEJI DEL RIO, HGO 42850 MX 42850 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2016-06-21 |