GLORI HYPO ALLERGENIC PRESSURE EARRINGS P-3747 W/SILICONE PAD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-07-20 for GLORI HYPO ALLERGENIC PRESSURE EARRINGS P-3747 W/SILICONE PAD manufactured by Padgett Instruments.

Event Text Entries

[21956162] Co received a call from nurse, and dr regarding a 6 yr. Old female who was using the glkori-hypo allergenic pressure earring after having a keloid removed from her right earlobe. She had a steroid injection in her left earlobe. The dr had his pt put the earrings on both ears 10 days after the surgery. The pt had been in twice since the surgery and everything was fine. On june 24th the mother was attempting to remove the earrings before her daughter went to bed. She could not remove them and the child was in distress. The decision was made to take her to the emergency room. Nurse said that the earrings were removed and that the pt suffered from tissue necrosis. The following morning, the dr debrided and repaired earlobes. Nurse said that dr had been using earrings for about 10 years and had not experienced any problems. She asked if padgett provided instructions or recommendations for use of these earrings. She was told that padget did not provide instructions on use of earrings because doctors were trained and their pts were to follow their dr's instructions. Nurse could not provide any additional information regarding this event. She was asked to have dr call co as soon as possible. On july 15th co received a call from dr. Dr could not understand what had happened regarding this pt. Dr stated he had received training on use of these earrings and he had never had any problems with them. Dr said his pt had been wearing these earrings overnight and that when her mother went to remove them she could not get them off the earlobes and the decision was made to take her to the emergency room. Co asked dr if there was any infection and he said no. Dr stated that when earrings were removed that there was moisture on earlobe. Dr did say that he tried these earrings on his earlobes and that they were not tight. Dr was at a total loss as to why this event had taken place. Co asked dr if it would be possible to sent in earrings for inspection and investigation. Dr said he did not have them to return to co for investigation. Padgett has sold these earrings for years. Co sell aprox 250-300 pairs per month. Co has never received a complaint.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1910735-1999-00002
• MDR Report Key: 233180
• Report Source: 05
• Date Received: 1999-07-20
• Date of Report: 1999-07-19
• Date of Event: 1999-06-24
• Date Facility Aware: 1999-06-24
• Report Date: 1999-07-19
• Date Reported to FDA: 1999-07-19
• Date Mfgr Received: 1999-06-24
• Device Manufacturer Date: 1999-05-01
• Date Added to Maude: 1999-07-28
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GLORI HYPO ALLERGENIC PRESSURE EARRINGS
• Generic Name: CHILDREN/UPPER EAR EARRINGS W/PAD
• Product Code: JYT
• Date Received: 1999-07-20
• Model Number: NA
• Catalog Number: P-3747 W/SILICONE PAD
• Lot Number: NA
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: 1 MO
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 226019
• Manufacturer: PADGETT INSTRUMENTS
• Manufacturer Address: 1730 WALNUT KANSAS CITY MO 64108 US
• Baseline Brand Name: GLORI HYPO ALLERGENIC PRESSURE EARRINGS
• Baseline Generic Name: CHILDREN/UPPER EAR EARRINGS W/PAD
• Baseline Model No: NA
• Baseline Catalog No: P-3747 W/SILICONE PAD
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-07-20