MAUDE Adverse Event Report: SGP01 SINGAPORE UNKNOWN PRODUCT-MED; PATIENT EXAMINATION GLOVE, SPECIALTY

Model Number UNKNOWN PRODUCT-MED

Device Problem Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 02/25/2018

Event Type  malfunction  

Manufacturer Narrative

At the time of this investigation no samples or lot numbers were provided.Lot numbers enable us to review the device history record (dhr), without the lot number we were not able to review the dhr to determine if there were issues during manufacturing.We were unable to determine the root cause for the reported complaint without the issue sample and lot number.At this time no corrective action will be taken.We will continue monitoring our customer complaints data base for this and any other issues reported of the same nature.

Event Description

Plaintiff alleges that the powder free nitrile select exam gloves distributed by (b)(4), which were worn by prisoner (b)(6)on the date of (b)(6) 2018, were defective as they reportedly would rupture and allow blood to drip from prisoners injury upon his hand onto the cups and utensils within the dining area's serving line.

• Brand Name: UNKNOWN PRODUCT-MED
• Type of Device: PATIENT EXAMINATION GLOVE, SPECIALTY
• Manufacturer (Section D): SGP01 SINGAPORE; 10 kallang avenue , #10-10/18; singapore 33951 0; SN 339510
• Manufacturer (Section G): SGP01 SINGAPORE; 10 kallang avenue , #10-10/18; singapore 33951 0; SN 339510
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 8788923
• MDR Text Key: 164254841
• Report Number: 1423537-2019-00332
• Device Sequence Number: 1
• Product Code: LZC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: UNKNOWN PRODUCT-MED
• Device Catalogue Number: UNKNOWN PRODUCT-MED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other