MAUDE Adverse Event Report: STRYKER GMBH 10 SILICONE PIP IMPLANT (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Model Number PIP-10

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/18/2020

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

Allergy was reported after implantation.

• Brand Name: 10 SILICONE PIP IMPLANT (STERILE PACKED)
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10587106
• MDR Text Key: 208565937
• Report Number: 0008031020-2020-02273
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00886385021515
• UDI-Public: 00886385021515
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K931588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PIP-10
• Device Catalogue Number: PIP10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR