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

Model Number 901071

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

While doctor was performing a vaginal exam, the plastic speculum broke causing vaginal lacerations.

• Brand Name: WELCH ALLYN, INC.
• Type of Device: SPECULUM, VAGINAL, NONMETAL
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street road; skaneateles falls NY 13153
• MDR Report Key: 13666366
• MDR Text Key: 286570153
• Report Number: 13666366
• Device Sequence Number: 1
• Product Code: HIB
• UDI-Device Identifier: 00732094103540
• UDI-Public: (01)00732094103540
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 02/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Female
• Patient Weight: 120 KG