MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-06 for ALWAYSLNRDAILIESFRESH&PRTCLONGODORCNTRL manufactured by Procter & Gamble Gmbh & Co. Manufacturing Ohe.
[56769424]
The reporter provided a production code and a product investigation is in progress. No returned sample has been received at the plant. Full evaluation will occur upon receipt of returned product.
Patient Sequence No: 1, Text Type: N, H10
[56769425]
Two (2) infections in (groin and) uterus [uterine infection]. Two (2) infections in groin (and uterus) [infection]. Itching due to gel-vagina [vulvovaginal pruritus]. Uncomfortable due to gel-vagina [vulvovaginal discomfort]. Red due to gel-vagina [vulvovaginal erythema]. Shiny due to gel-vagina [vaginal disorder]. Painful due to gel-vagina [vulvovaginal pain]. Uncomfortable due to gel-all other creases in this area-female genitals [genital discomfort]. Red due to gel-all other creases in this area-female genitals [genital erythema]. Shiny due to gel-all other creases in this area-female genitals [genital disorder female]. Pain due to gel-all other creases in this area-female genitals [genital pain]. Itching due to gel-all other creases in this area-female genitals [pruritus genital]. Quite ill [malaise]. Case description: a female consumer, age unspecified, reported on 18-jul-2016 via letter using always liners dailies fresh & protect long odor control for 1 week, beginning on an unknown date, and experienced the following symptoms on her vagina and all other creases in this area: very bright red, shiny, painful and itching. She stated that the pain kept her awake all night and she could not sleep because of the terrible itching. She described that she had a very uncomfortable week with the special large gel ones. She reported that she visited her doctor who did not know what it was as she had never seen it before on a patient and supplied her with 3 pots of cetraben cream and 1 tube of eumovate hydrochloride 10mg. The consumer also took cetirizine tablets for her symptoms, sending in an empty bit of wrapper from the medication packaging. She stated that although the advertisement for the product claims the gel on them is very soothing, it was not for her, and she has never had anything wrong before she started using the pad as the green ones have always been fine for her. She reported that her itching and pain have not gone away. The case outcome was not recovered/not resolved. No further information was provided. On 06-sep-2016 consumer follow-up: the consumer reported that she had a phone call today from her doctor and she does have 2 infections in her groin and uterus and it is now urgent, as she is about to go into hospital on (b)(6) 2016. She stated that swabs have been taken and most medications for this area of the body have been used. She reported that she is not getting any joy now for 14 weeks and as perfume exists in the blue gel on the pads she was requesting a list of its components to help her doctor know if what is being used is ok for anyone. She stated that she has been quite ill with itching. The case outcome remained not recovered/not resolved. No further information was provided. On 23-sep-2016 consumer follow-up: the consumer reported that she went into the hospital for a heat managing box and it would not start, even the consultant tried to get it working. She stated that they asked her if she had any kind of perfume on as this was not allowed, and she forgot that she had one of the pads at the time. She reported that she has had this infection for 4 months and is now using plain white pads for the last 10 days and slowly it is getting better. The case outcome was improved. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[59251494]
The production lot code and product description provided by the reporter were accurate and legitimate. Review of batch manufacturing and quality records indicated the product was manufactured as intended. No returned sample has been received at the plant. Full evaluation will occur upon receipt of returned product.
Patient Sequence No: 1, Text Type: N, H10
[59251495]
Two (2) infections in (groin and) uterus [uterine infection]. Two (2) infections in groin (and uterus) [infection]. Itching due to gel-vagina [vulvovaginal pruritus]. Uncomfortable due to gel-vagina [vulvovaginal discomfort]. Red due to gel-vagina [vulvovaginal erythema]. Shiny due to gel-vagina [vaginal disorder]. Painful due to gel-vagina [vulvovaginal pain]. Uncomfortable due to gel-all other creases in this area-female genitals [genital discomfort]. Red due to gel-all other creases in this area-female genitals [genital erythema]. Shiny due to gel-all other creases in this area-female genitals [genital disorder female]. Pain due to gel-all other creases in this area-female genitals [genital pain]. Itching due to gel-all other creases in this area-female genitals [pruritus genital]. Quite ill [malaise]. Case description: a female consumer, age unspecified, reported on 18-jul-2016 via letter using always liners dailies fresh & protect long odor control for 1 week, beginning on an unknown date, and experienced the following symptoms on her vagina and all other creases in this area: very bright red, shiny, painful and itching. She stated that the pain kept her awake all night and she could not sleep because of the terrible itching. She described that she had a very uncomfortable week with the special large gel ones. She reported that she visited her doctor who did not know what it was as she had never seen it before on a patient and supplied her with 3 pots of cetraben cream and 1 tube of eumovate hydrochloride 10mg. The consumer also took cetirizine tablets for her symptoms, sending in an empty bit of wrapper from the medication packaging. She stated that although the advertisement for the product claims the gel on them is very soothing, it was not for her, and she has never had anything wrong before she started using the pad as the green ones have always been fine for her. She reported that her itching and pain have not gone away. The case outcome was not recovered/not resolved. No further information was provided. On 06-sep-2016 consumer follow-up: the consumer reported that she had a phone call today from her doctor and she does have 2 infections in her groin and uterus and it is now urgent, as she is about to go into hospital on (b)(6) 2016. She stated that swabs have been taken and most medications for this area of the body have been used. She reported that she is not getting any joy now for 14 weeks and as perfume exists in the blue gel on the pads she was requesting a list of its components to help her doctor know if what is being used is ok for anyone. She stated that she has been quite ill with itching. The case outcome remained not recovered/not resolved. No further information was provided. On 23-sep-2016 consumer follow-up: the consumer reported that she went into the hospital for a heat managing box and it would not start, even the consultant tried to get it working. She stated that they asked her if she had any kind of perfume on as this was not allowed, and she forgot that she had one of the pads at the time. She reported that she has had this infection for 4 months and is now using plain white pads for the last 10 days and slowly it is getting better. The case outcome was improved. No further information was provided. On 24-oct-2016 batch manufacturing records review: l1 investigation w/o returned pad 24 october 2016: the production lot code and product description was accurate and legitimate at the time of the intake call. Sap production planning and confirmation records confirmed that line 34 produced brand code 83729436 (alw cbo xlng onmm vp 4x44 prosp2 uk c1) process order (b)(4) on julian date (6155) june 04th 2016 from 04:28am. Quality reports passed quality assurance criteria to release and ship brand code (b)(4) to confirm that the product was manufactured as intended. The site quality alert system was searched for the production code identified and selected time frame before and after the production date and there were no quality events on that line. We know that some consumers react sensitive to our onm / perfumed products. The related onm/scent process parameters were on target to conform that we produce inside our formula card limits. The results of this investigation indicated that the subject product was manufactured as intended according to our standards. No samples associated with this complaint have been received for evaluation, however, should samples be received subsequent to this review the samples will be assessed and the investigation will be re-evaluated to determine if any additional steps are required. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680085-2016-00003 |
| MDR Report Key | 6003417 |
| Date Received | 2016-10-06 |
| Date of Report | 2016-07-18 |
| Date Mfgr Received | 2016-10-24 |
| Date Added to Maude | 2016-10-06 |
| 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 GMBH & CO. MANUFACTURING OHE |
| Manufacturer Street | P&G STRASSE 1 D-74564 |
| Manufacturer City | CRAILSHEIM, D-7180 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-7180 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALWAYSLNRDAILIESFRESH&PRTCLONGODORCNTRL |
| Generic Name | PAD, MENSTRUAL, SCENTED |
| Product Code | HHL |
| Date Received | 2016-10-06 |
| Lot Number | 6155031434B04:28 P 03/06/16 |
| ID Number | NOT AVAILABLE |
| 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 GMBH & CO. MANUFACTURING OHE |
| Manufacturer Address | P&G STRASSE 1 D-74564 CRAILSHEIM, D-7180 GM D-7180 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-06 |