MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS SILICONE PIP SZ. 1

Catalog Number SPIP-520-1-WW

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

The device from this incident has not been returned (or explanted) to date.However, investigation performed and confirmed that units in lot 192715t showed size 0 on the inner pouch label and size 1 on the outer pouch label.Review of manufacturing records for spip-520-1-ww lot 192715t showed no evidence of a nonconformance that may have caused or contributed to the reported event.The labels included in the dhr show size 1 reflected on the inner pouch, outer pouch, and box labels.The reported complaint was confirmed.

Event Description

A nurse reported that on (b)(6) 2019, a silicone pip (id spip-520-1-ww ¿ sze.1) has been identified as having a potential issue with labeling discrepancies related to the size of the implant on the label, indicating a size 0 while the outer labels indicated size 1.Since the complaint was issued, all units have been removed from the field.No patient injury was reported.The patient, the facility, and the physician have not indicated any type of displeasure with the outcome of the case.Patient recovered well as there has been no feedback from the field indicating otherwise.

• Brand Name: SILICONE PIP SZ. 1
• Type of Device: SILICONE PIP
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362319
• MDR Report Key: 9209690
• MDR Text Key: 201252209
• Report Number: 1651501-2019-00043
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• PMA/PMN Number: K082231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SPIP-520-1-WW
• Device Lot Number: 192715T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1