MAUDE Adverse Event Report: WELCH ALLYN, INC. WELCH ALLYN, INC.; SPECULUM, VAGINAL, NONMETAL

Model Number	901071
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While doctor was performing a vaginal exam, the plastic speculum broke causing vaginal lacerations.

• Brand Name: WELCH ALLYN, INC.
• Common Device Name: SPECULUM, VAGINAL, NONMETAL
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street road; skaneateles falls NY 13153
• MDR Report Key: 13666366
• Report Number: 13666366
• Device Sequence Number: 4893639
• Product Code: HIB
• UDI-Device Identifier: 00732094103540
• UDI-Public: (01)00732094103540
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/22/2022
• Report Date (Section F): 02/22/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 901071
• Device Catalogue Number: 58000S-B
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 120 KG
• Date Report Sent to FDA: 02/22/2022