OB SUPER 48 S EU
Report
- Report Number
- 2214133-2012-00346
- Event Type
- Injury
- Date Received
- September 13, 2012
- Report Date
- August 30, 2012
- Manufacturer
- NI
- Product Code
- HEB
- PMA / PMN Number
- K974629
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
THIS FOREIGN REPORT IS BEING SUBMITTED (B)(4) FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (OB SUPER PLUS NON-APPLICATOR 40S). THE MANUFACTURER REPORT NUMBER FOR THE FIRST PRODUCT IS 2214133-2012-00346. THE MANUFACTURER REPORT NUMBER FOR THE SECOND PRODUCT IS 2214133-2012-00347. THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED.
THIS FOREIGN REPORT IS BEING SUBMITTED (B)(4) 2012, FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (OB SUPER PLUS NON-APPLICATOR 40S). THIS IS AN INITIAL SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 2214133-2012-00346. THE INITIAL SUBMISSION FOR THE SECOND PRODUCT IN THIS CASE WILL HAVE THE MANUFACTURER REPORT NUMBER 2214133-2012-00347.THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED.
THIS FOREIGN REPORT IS BEING SUBMITTED (B)(4) FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (OB SUPER PLUS NON-APPLICATOR 40S). THE MANUFACTURER REPORT NUMBER FOR THE FIRST PRODUCT IS 2214133-2012-00346. THE MANUFACTURER REPORT NUMBER FOR THE SECOND PRODUCT IS 2214133-2012-00347. THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED.
THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012, FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM (B)(6). THE MEDICAL HISTORY OF THE CONSUMER AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING OB SUPER 48S, FOR MENSTRUATION (ROUTE: VAGINAL, LOT NUMBER B0462W63, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, ON (B)(6) 2012, THE GYNECOLOGIST WAS CONSULTED FOR ROUTINE EXAMINATION AND NOTICED THAT THE COTTON WOOL DETACHED FROM THE TAMPON WHICH GOT STUCK IN HER VAGINA AND THE GYNECOLOGIST REMOVED THE PART OF THE TAMPON FROM HER VAGINA. THE GYNECOLOGIST ALSO PRESCRIBED HER WITH UNSPECIFIED DRUGS TO TREAT THE BACTERIAL INFECTION. THE CONSUMER MENTIONED THAT HER LAST MENSTRUATION ENDED TWO DAYS PRIOR TO CONSULTING THE GYNECOLOGIST. THE CONSUMER FOUND ANOTHER RESIDUAL COTTON WOOL WITHIN THE BOX. SHE STATED THE USAGE OF MORE THAN ONE TAMPON FROM THE SAME BOX. SHE ALSO STATED TO HAVE THE USAGE OF DEVICE IN THE PAST FOR YEARS WITHOUT ANY ADVERSE EVENT. THE ACTION TAKEN WITH THE DEVICES WERE UNKNOWN. THE EVENT OF BACTERIAL INFECTION DID NOT RESOLVE. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.
THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM (B)(6). THE MEDICAL HISTORY OF THE CONSUMER AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING OB SUPER 48S, FOR MENSTRUATION (ROUTE: VAGINAL, LOT NUMBER B0462W63, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, ON (B)(6) 2012, THE GYNECOLOGIST WAS CONSULTED FOR ROUTINE EXAMINATION AND NOTICED THAT THE COTTON WOOL DETACHED FROM THE TAMPON WHICH GOT STUCK IN HER VAGINA AND THE GYNECOLOGIST REMOVED THE PART OF THE TAMPON FROM HER VAGINA. THE GYNECOLOGIST ALSO PRESCRIBED HER WITH UNSPECIFIED DRUGS TO TREAT THE BACTERIAL INFECTION. THE CONSUMER MENTIONED THAT HER LAST MENSTRUATION ENDED TWO DAYS PRIOR TO CONSULTING THE GYNECOLOGIST. THE CONSUMER FOUND ANOTHER RESIDUAL COTTON WOOL WITHIN THE BOX. SHE STATED THE USAGE OF MORE THAN ONE TAMPON FROM THE SAME BOX. SHE ALSO STATED TO HAVE THE USAGE OF DEVICE IN THE PAST FOR YEARS WITHOUT ANY ADVERSE EVENT. THE ACTION TAKEN WITH THE DEVICES WERE UNKNOWN. THE EVENT OF BACTERIAL INFECTION DID NOT RESOLVE. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012. FOR OB SUPER 48S, SIXTEEN SAMPLES HAD BEEN RECEIVED FROM THE CONSUMER AND TEN SAMPLES HAD BEEN ANALYZED, NO DEVICE DEFECT COULD BE FOUND. TO FOLLOW UP, MORE SPECIFIC DESCRIPTION OF THE PARTICULAR DEFECT OR A DEFECT SAMPLES WOULD BE REQUIRED. THIS REPORT REMAINS SERIOUS (REQUIRED INTERVENTION). THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED FROM THE GYNECOLOGIST ON (B)(4) 2012. THE LAST MENSTRUATION OF THE CONSUMER HAD STARTED ON (B)(6) 2012. THE GYNECOLOGIST WAS CONSULTED ON (B)(6) 2012 FOR A ROUTINE PREVENTIVE MEDICAL EXAMINATION. DURING THE VAGINAL INSPECTION, THE GYNECOLOGIST DETECTED A REST OF GRAYISH COLORED WADDING MATERIAL IN THE POSTERIOR VAGINAL VAULT. THE PIECE OF WADDING MATERIAL WAS APPROXIMATELY 2 CM X 0.5 CM WITH NO COVER OR WITHDRAWAL CORD MATERIALS VISIBLE ON IT AND IT WAS DISCARDED. THE GYNECOLOGIST NOTED VAGINAL FINDINGS AS NO ACUTE VAGINAL COLPITIS/VAGINITIS, BUT LEUCOCYTES MINIMALLY POSITIVE. THE GYNECOLOGIST PRESCRIBED HER WITH VAGI-HEX (HEXETIDINE AS VAGINAL DISINFECTANT) AND GYNOPHILUS (LACTOBACILLI) AS TOPICAL VAGINAL DRUGS IN ORDER TO STABILIZE THE VAGINAL MILIEU. AFTER AN UNSPECIFIED DURATION, THE EVENT RESOLVED. THE GYNECOLOGIST RECOMMENDED THE CONSUMER TO CONTINUE THE USE OF O.B. TAMPONS AND THE CONSUMER STATED THE USAGE OF O.B. TAMPONS ALSO DURING THE LAST MENSTRUATION. AN ADDITIONAL TREATMENT OR THE FOLLOW UP WAS NOT GIVEN. THIS REPORT REMAINS SERIOUS (REQUIRED INTERVENTION). THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.
THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM (B)(6). THE MEDICAL HISTORY OF THE CONSUMER AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING OB SUPER 48S, FOR MENSTRUATION (ROUTE: VAGINAL, LOT NUMBER B0462W63, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, ON (B)(6) 2012, THE GYNECOLOGIST WAS CONSULTED FOR ROUTINE EXAMINATION AND NOTICED THAT THE COTTON WOOL DETACHED FROM THE TAMPON WHICH GOT STUCK IN HER VAGINA AND THE GYNECOLOGIST REMOVED THE PART OF THE TAMPON FROM HER VAGINA. THE GYNECOLOGIST ALSO PRESCRIBED HER WITH UNSPECIFIED DRUGS TO TREAT THE BACTERIAL INFECTION. THE CONSUMER MENTIONED THAT HER LAST MENSTRUATION ENDED TWO DAYS PRIOR TO CONSULTING THE GYNECOLOGIST. THE CONSUMER FOUND ANOTHER RESIDUAL COTTON WOOL WITHIN THE BOX. SHE STATED THE USAGE OF MORE THAN ONE TAMPON FROM THE SAME BOX. SHE ALSO STATED TO HAVE THE USAGE OF DEVICE IN THE PAST FOR YEARS WITHOUT ANY ADVERSE EVENT. THE ACTION TAKEN WITH THE DEVICES WERE UNKNOWN. THE EVENT OF BACTERIAL INFECTION DID NOT RESOLVE. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012. FOR OB SUPER 48S, SIXTEEN SAMPLES HAD BEEN RECEIVED FROM THE CONSUMER AND TEN SAMPLES HAD BEEN ANALYZED, NO DEVICE DEFECT COULD BE FOUND. TO FOLLOW UP, MORE SPECIFIC DESCRIPTION OF THE PARTICULAR DEFECT OR A DEFECT SAMPLES WOULD BE REQUIRED. THIS REPORT REMAINS SERIOUS (REQUIRED INTERVENTION). THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OB SUPER 48 S EU | TAMPON | HEB | NI | BSUPER6012 | B0462W63 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |