MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO MULTI-PURPOSE SKULL CLAMP (SET); DORO® MULTI-PURPOSE SKULL CLAMP (SET)

Model Number 3020-00

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

Patient Problems Skin Discoloration (2074); Injury (2348)

Event Date 04/19/2020

Event Type  Injury  

Manufacturer Narrative

No evaluation possible as the device was not returned.We suspect that the skin damage was caused due to improper positioning of the patients head.

Event Description

Quality management was contacted on 15th of july 2020 from customer.Customer stated a pressure injury and pink skin relating to the use of a doro® multi-purpose skull clamp (set).

• Brand Name: DORO MULTI-PURPOSE SKULL CLAMP (SET)
• Type of Device: DORO® MULTI-PURPOSE SKULL CLAMP (SET)
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: christopher schmitz ; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 10452777
• MDR Text Key: 204339733
• Report Number: 3003923584-2020-00017
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435501573
• UDI-Public: 04250435501573
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K001808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3020-00
• Device Catalogue Number: 3020-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2018
• 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: 9 YR