MAUDE Adverse Event Report: M AND C SCHIFFER GMBH DR. BEST BAMBUS UNKNOWN; TOOTHBRUSHES

Device Problem Product Quality Problem (1506)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Bleeding [hemorrhage], injured [injury].Case description: this case was reported by a consumer via call center representative and described the occurrence of bleeding in a (b)(6) year-old female patient who received gsk toothbrush (dr.Best bambus unknown) toothbrush (batch number unk, expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started dr.Best bambus unknown.On an unknown date, an unknown time after starting dr.Best bambus unknown, the patient experienced bleeding (serious criteria gsk medically significant), injury and product complaint.The action taken with dr.Best bambus unknown was unknown.On an unknown date, the outcome of the bleeding, injury and product complaint were unknown.It was unknown if the reporter considered the bleeding and injury to be related to dr.Best bambus unknown.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: adverse event information received via call center representative on 15-jun-2021.The consumer stated that, "we switched to the dr.Best bambus and injured ourselves while using it.It is not handy.It is too wide and sharp-edged.That was the bambus interdent.We don't have a lot number." follow up information was received on 21 jun 2021 from quality assurance (qa) department regarding pqc number: pqc91100 for lot number unknown.The investigation reports concluded that, complaint stands unsubstantiated.Investigation and evaluation: the review of manufacturing / packaging batch records did not indicate that this complaint may be due to a processing problem.No recall has been started by this article.Further investigation is not possible without receiving the complaint sample.This complaint has been logged and will be evaluated and present in the monthly complaint review process.On the basis of the above the complaint is considered as closed.With the receipt of the complaint sample, the complaint will be re-opened and further investigation carried out as required.A final report will be issued in accordance with the quality agreement within 30 days after receiving the complaint sample.This case is created for the reporter and linked to another case with same reporter, same product, different patient with case id: (b)(4).

• Brand Name: DR. BEST BAMBUS UNKNOWN
• Type of Device: TOOTHBRUSHES
• Manufacturer (Section D): M AND C SCHIFFER GMBH; neustadt/weid, ; GM
• MDR Report Key: 12084922
• MDR Text Key: 269385625
• Report Number: 9615008-2021-00017
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR