GSK TOOTHBRUSH
Report
- Report Number
- 9615008-2020-00007
- Event Type
- Injury
- Date Received
- July 21, 2020
- Report Date
- June 23, 2020
- Manufacturer
- M AND C SCHIFFER GMBH
- Product Code
- EFW
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
ARGUS CASE (B)(4).
DISGUSTING TO HAVE SUCH A BRISTLE IN THE THROAT AREA [FOREIGN BODY IN THROAT]. GAGGING REACTION/GAG REFLEX DUE TO THE BRISTLES [GAGGING]. DISGUSTING TO HAVE SUCH A BRISTLE IN THE MOUTH AREA [FOREIGN BODY IN MOUTH]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF GAGGING IN A FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH TOOTHBRUSH FOR ORAL HYGIENE. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED GSK TOOTHBRUSH. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING GSK TOOTHBRUSH, THE PATIENT EXPERIENCED GAGGING, FOREIGN BODY IN THROAT (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), FOREIGN BODY IN MOUTH AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH GSK TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE GAGGING, FOREIGN BODY IN THROAT, FOREIGN BODY IN MOUTH AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE GAGGING, FOREIGN BODY IN THROAT AND FOREIGN BODY IN MOUTH TO BE RELATED TO GSK TOOTHBRUSH. ADDITIONAL DETAILS, THE CONSUMER COMPLAINED ABOUT THE INFERIOR QUALITY OF THE TOOTHBRUSHES.SHE HAD BOUGHT 2 PACKS DR. BEST PREMIUM SPORTS EDITION TOOTHBRUSHES.AFTER USING THE FIRST TOOTHBRUSH SHE HAD A STRANGLEHOLD BECAUSE OF PROSTHETIC BRISTLES. SHE IMMEDIATELY DISPOSED IT AND ATTEMPTED TO USE THE SECOND TOOTHBRUSH FOR 4 DAYS, AND AGAIN, THE BRISTLES GOT OUT OF THE USE AND IN THE NEXT STEP THE BRISTLE DISSOLVED. PATIENT REPORTED THAT IT WAS DISGUSTING TO HAVE SUCH A BRISTLE IN THE NECK OR MOUTH AREA AND ALSO DANGEROUS. FOLLOW UP WAS RECEIVED FROM QUALITY ASSURANCE DEPARTMENT ON 26 JUN 2020 REGARDING COMPLAINT ((B)(4)),ALL GSK PRODUCTS ARE PRODUCED ACCORDING TO APPLICABLE STANDARDS AND APPROVED SPECIFICATIONS. THE PRODUCT COMPLAINT WAS CONSIDERED TO BE UNSUBSTANTIATED. FOLLOW UP WAS RECEIVED FROM QUALITY ASSURANCE DEPARTMENT ON 02 JUL 2020 REGARDING COMPLAINT ((B)(4)).TREND ANALYSIS WITH SAME PRODUCT OF COMPLAINT SUBJECT SHOWED NO ABNORMALITIES.FURTHER INVESTIGATION WAS NOT POSSIBLE WITHOUT RECEIVING THE BATCH NUMBER OR COMPLAINT SAMPLE. THIS COMPLAINT WAS LOGGED AND WILL BE EVALUATED AND PRESENT IN THE MONTHLY COMPLAINT REVIEW PROCESS. ON THE BASIS OF THE ABOVE THE COMPLAINT WAS CONSIDERED AS CLOSED. WITH THE RECEIPT OF THE COMPLAINT SAMPLE, THE COMPLAINT WOULD BE RE-OPENED AND FURTHER INVESTIGATION CARRIED OUT AS REQUIRED. A FINAL REPORT WOULD BE ISSUED IN ACCORDANCE WITH THE QUALITY AGREEMENT WITHIN 30 DAYS AFTER RECEIVING THE COMPLAINT SAMPLE. THE COMPLAINT WAS CONSIDERED TO BE UNSUBSTANTIATED. NO MANUFACTURING ERROR WAS DETECTED. FOLLOW UP WAS RECEIVED FROM QUALITY ASSURANCE DEPARTMENT ON 13 JUL 2020 REGARDING COMPLAINT ((B)(4)) AND BATCH NUMBER M 93254385 A .PRODUCT WAS MONITORED AND DOCUMENTED BY PRODUCTION CONTROL IN EACH SHIFT. DEVIATIONS WERE NOT DOCUMENTED. FURTHER INVESTIGATION WAS NOT POSSIBLE WITHOUT RECEIVING THE COMPLAINT SAMPLE. VALUES FOR TRF AND NUMBER OF FILAMENTS WERE WITHIN SPECIFICATIONS. THE DIAMETER OF FILAMENTS ALSO IN SPECIFICATIONS.ON THE BASIS OF THE ABOVE THE COMPLAINT WAS CONSIDERED AS CLOSED.THE COMPLAINT WAS CONSIDERED AS UNSUBSTANTIATED.THE BATCH NUMBER WAS UPDATED AS M 93254385 A. FOLLOW UP INFORMATION WAS RECEIVED ON 27-OCT-2020, THE CONSUMER DID NOT VISIT AN HEALTH CARE PROFESSIONAL (SHE WAS ABLE TO REMOVE THE FOREIGN BODY ON HER OWN) WAS PROVIDED. CONTACT LOGS HAD BEEN CLOSED AS FOLLOW UP DENIED. THE PHYSICIAN WAS NOT WILLING TO PROVIDE CONTACT DETAILS FROM PHYSICIAN, CONSUMER DID NOT WANTED TO FILL IN THE CONSENT FORM. BESIDES, THE CONSUMER DID NOT WANT TO FILL IN THE FORM HERSELF EITHER. AS SAID SEVERAL TIMES ON THE PHONE, SHE REPORTED THAT, SHE HAD NO INTEREST IN FOLLOWING UP ON THIS INCIDENT. SHE ALSO INDICATED THAT NO DOCTOR'S VISIT WAS NECESSARY. SHE WAS ABLE TO REMOVE THE BRISTLE OUT ON HER OWN. SHE WOULD NEVER BUY THIS PRODUCT AGAIN, SO, SHE WOULD NOT SEND THE DOCUMENTATION SHEET BACK. GSK TOOTHBRUSH WAS DISCONTINUED (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE FOREIGN BODY IN THROAT AND FOREIGN BODY IN MOUTH WERE RECOVERED/RESOLVED.
ARGUS CASE (B)(4).
GAGGING REACTION/GAG REFLEX DUE TO THE BRISTLES [GAGGING]. DISGUSTING TO HAVE SUCH A BRISTLE IN THE THROAT AREA [FOREIGN BODY IN THROAT]. DISGUSTING TO HAVE SUCH A BRISTLE IN THE MOUTH AREA [FOREIGN BODY IN MOUTH]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF GAGGING IN A FEMALE PATIENT WHO RECEIVED GSK TOOTHBRUSH TOOTHBRUSH FOR ORAL HYGIENE. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE PATIENT STARTED GSK TOOTHBRUSH. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING GSK TOOTHBRUSH, THE PATIENT EXPERIENCED GAGGING, FOREIGN BODY IN THROAT (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), FOREIGN BODY IN MOUTH AND PRODUCT COMPLAINT. THE ACTION TAKEN WITH GSK TOOTHBRUSH WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE GAGGING, FOREIGN BODY IN THROAT, FOREIGN BODY IN MOUTH AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE GAGGING, FOREIGN BODY IN THROAT AND FOREIGN BODY IN MOUTH TO BE RELATED TO GSK TOOTHBRUSH. ADDITIONAL DETAILS, THE CONSUMER COMPLAINED ABOUT THE INFERIOR QUALITY OF THE TOOTHBRUSHES. SHE HAD BOUGHT 2 PACKS DR. BEST PREMIUM SPORTS EDITION TOOTHBRUSHES. AFTER USING THE FIRST TOOTHBRUSH SHE HAD A STRANGLEHOLD BECAUSE OF PROSTHETIC BRISTLES. SHE IMMEDIATELY DISPOSED IT AND ATTEMPTED TO USE THE SECOND TOOTHBRUSH FOR 4 DAYS, AND AGAIN, THE BRISTLES GOT OUT OF THE USE AND IN THE NEXT STEP THE BRISTLE DISSOLVED. PATIENT REPORTED THAT IT WAS DISGUSTING TO HAVE SUCH A BRISTLE IN THE NECK OR MOUTH AREA AND ALSO DANGEROUS. FOLLOW UP WAS RECEIVED FROM QUALITY ASSURANCE DEPARTMENT ON 26 JUN 2020 REGARDING COMPLAINT ((B)(4)), ALL GSK PRODUCTS ARE PRODUCED ACCORDING TO APPLICABLE STANDARDS AND APPROVED SPECIFICATIONS. THE PRODUCT COMPLAINT WAS CONSIDERED TO BE UNSUBSTANTIATED. FOLLOW UP WAS RECEIVED FROM QUALITY ASSURANCE DEPARTMENT ON 02 JUL 2020 REGARDING COMPLAINT ((B)(4)). TREND ANALYSIS WITH SAME PRODUCT OF COMPLAINT SUBJECT SHOWED NO ABNORMALITIES. FURTHER INVESTIGATION WAS NOT POSSIBLE WITHOUT RECEIVING THE BATCH NUMBER OR COMPLAINT SAMPLE. THIS COMPLAINT WAS LOGGED AND WILL BE EVALUATED AND PRESENT IN THE MONTHLY COMPLAINT REVIEW PROCESS. ON THE BASIS OF THE ABOVE THE COMPLAINT WAS CONSIDERED AS CLOSED. WITH THE RECEIPT OF THE COMPLAINT SAMPLE, THE COMPLAINT WOULD BE RE-OPENED AND FURTHER INVESTIGATION CARRIED OUT AS REQUIRED. A FINAL REPORT WOULD BE ISSUED IN ACCORDANCE WITH THE QUALITY AGREEMENT WITHIN 30 DAYS AFTER RECEIVING THE COMPLAINT SAMPLE. THE COMPLAINT WAS CONSIDERED TO BE UNSUBSTANTIATED. NO MANUFACTURING ERROR WAS DETECTED. FOLLOW UP WAS RECEIVED FROM QUALITY ASSURANCE DEPARTMENT ON 13 JUL 2020 REGARDING COMPLAINT ((B)(4)) AND BATCH NUMBER M 93254385 A .PRODUCT WAS MONITORED AND DOCUMENTED BY PRODUCTION CONTROL IN EACH SHIFT. DEVIATIONS WERE NOT DOCUMENTED. FURTHER INVESTIGATION WAS NOT POSSIBLE WITHOUT RECEIVING THE COMPLAINT SAMPLE. VALUES FOR TRF AND NUMBER OF FILAMENTS ARE WITHIN SPECIFICATIONS. THE DIAMETER OF FILAMENTS ALSO IN SPECIFICATIONS. ON THE BASIS OF THE ABOVE THE COMPLAINT WAS CONSIDERED AS CLOSED. THE COMPLAINT WAS CONSIDERED AS UNSUBSTANTIATED. THE BATCH NUMBER WAS UPDATED AS M 93254385 A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 769828 | GSK TOOTHBRUSH | TOOTHBRUSHES | EFW | M AND C SCHIFFER GMBH | M 93254385 A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |