MAUDE Adverse Event Report: PROCTER & GAMBLE MFG MEXICO S DE RL DE CV ORALBMANDENTALFLOSSSATINFLOSS; FLOSS, DENTAL

Lot Number NOT AVAILABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

Product return was requested and a follow-up questionnaire has been sent to the reporter, but neither has been received at this time.Please note that the reporter in this case was a third party individual and not the individual or family.A valid production code has been provided by the reporter, however, the production code identifies the product as being beyond the expected shelf life, no further product investigation will be done at this time.Further evaluation may occur upon receipt of the consumer product and/or the questionnaire.

Event Description

Allergic reaction [hypersensitivity].Swelling- face [swelling face].Lip swelling [lip swelling].Case description: a spontaneous report was received via e-mail on 13-jul-2019 from a dental hygienist stating her neighbor, who was also her patient, informed her that her (b)(6) year old son used oral-b complete satin floss beginning on an unspecified date, and experienced an allergic reaction in (b)(6) 2018.He had experienced swelling after flossing twice in the past.On the day of the reaction in (b)(6) 2018, his father treated him with aerius due to the appearance of his face.He did not improve so was taken to the hospital where he was treated with benadryl and an epipen injection.The outcome was not reported.The reporter stated the child had just finished allergy testing.He was allergic to formaldehyde, neomycin, cobalt (ii) chloride-hexahydrate, and 2-bromo-2-nitropropane-1,3-diol.The case outcome was unknown.Concomitant product(s): none reported.No further information was provided.On 17-jul-2019 follow-up via e-mail: the reporter stated her neighbor's son only had a bit of swelling on his lip the first two times he reacted to the product, and his reaction in (b)(6) 2018 was the most severe.The swelling has completely resolved.The case outcome was recovered.No further information was provided.

• Brand Name: ORALBMANDENTALFLOSSSATINFLOSS
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): PROCTER & GAMBLE MFG MEXICO S DE RL DE CV; calle cuatro no. 4; naucalpan, 53370 ; MX 53370
• Manufacturer (Section G): PROCTER & GAMBLE MFG MEXICO S DE RL DE CV; calle cuatro no. 4; naucalpan, 53370 ; MX 53370
• Manufacturer Contact: regulatory oral care ; 8700 mason-montgomery rd; mason, OH 45040
• MDR Report Key: 8885842
• MDR Text Key: 154181979
• Report Number: 9710651-2019-00001
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2019
• Initial Date FDA Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR