MAUDE Adverse Event Report: INTEGRA YORK, PA INC. UW RUB. DAM CLAMP FCPS; M51 - GENERAL DENTISTRY

Catalog Number 76-15

Device Problem Break (1069)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported the rubber dam clamp forceps broke during a dental procedure resulting in a chipped lower lateral tooth.The patient was complaining of pain and discomfort and the tooth was repaired with filling.The broken piece was retrieved, and the patient is doing well.

Event Description

N/a.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).Rubber dam clamps were not returned for evaluation (they purchased additional rubber dam clamps as a replacement); however, image was provided and evaluated: per the provided image, these 76-15 forceps are in used condition with the tips broken off due to rough handling or excessive force.The reported complaint is confirmed.No further investigation required based on the acceptability of risk and no adverse trends identified.No manufacturing, workmanship or material deficiency has been identified.Additional information received - there was a delay for 20 minutes because tooth number 24 incisal lingual edged was chipped when the clamps broke.

• Brand Name: UW RUB. DAM CLAMP FCPS
• Type of Device: M51 - GENERAL DENTISTRY
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 10782684
• MDR Text Key: 214522829
• Report Number: 2523190-2020-00126
• Device Sequence Number: 1
• Product Code: EJG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 76-15
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1