MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-16 for CLINT PHARMACEUTICALS SINGLE-SHOT EPIDURAL TRAY NA manufactured by Clint Pharmaceuticals.
[3591112]
A (b)(6) year old male underwent a catheter-assisted caudal epidural steroid injection on (b)(6) 2013 without incident or complication. On (b)(6) 2013, pt arrived at office before open hours wanting to be seen. He did not wait, and reported to a local er, complaining of increased low back pain for 3 days. He had been nearly pain-free of his low back pain for 7 days following the procedure. He was treated for a "phlegmon at the s4 level in the subcutaneous tissues" with iv antibiotics and sent home from the er (at (b)(6)). He presented to the same er again later that day with fever and worst back pain, and was transferred to (b)(6). He was admitted as inpatient for antibiotic therapy, and improved until (b)(6) 2013 when suffered a pulmonary embolism and was admitted to icu. All cultures negative to this point. Lumbar puncture performed (b)(6) 2013 - clear yellow fluid obtained. The pt was treated with antibiotics for pseudomonas meningitis. He deteriorated and expired on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031523 |
| MDR Report Key | 3305269 |
| Date Received | 2013-08-16 |
| Date of Report | 2013-08-14 |
| Date of Event | 2013-07-01 |
| Date Added to Maude | 2013-08-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINT PHARMACEUTICALS SINGLE-SHOT EPIDURAL TRAY |
| Generic Name | EPIDURAL INJECTION PROCEDURE TRAY |
| Product Code | OGJ |
| Date Received | 2013-08-16 |
| Catalog Number | NA |
| Lot Number | 2231031 |
| Device Expiration Date | 2015-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINT PHARMACEUTICALS |
| Manufacturer Address | 629 SHUTE LANE OLD HICKORY TN 37138 US 37138 |
| Brand Name | CLINT PHARMACEUTICALS SINGLE-SHOT EPIDURAL TRAY |
| Generic Name | EPIDURAL INJECTION PROCEDURE TRAY |
| Product Code | OGJ |
| Date Received | 2013-08-16 |
| Model Number | ACL5SP |
| Catalog Number | NA |
| Lot Number | 2412580 |
| Device Expiration Date | 2015-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | CLINT PHARMACEUTICALS |
| Manufacturer Address | 629 SHUTE LANE OLD HICKORY TN 37138 US 37138 |
| Brand Name | CLINT PHARMACEUTICALS SINGLE-SHOT EPIDURAL TRAY |
| Generic Name | EPIDURAL INJECTION PROCEDURE TRAY |
| Product Code | OGJ |
| Date Received | 2013-08-16 |
| Lot Number | 2251094 |
| Device Expiration Date | 2015-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | CLINT PHARMACEUTICALS |
| Manufacturer Address | 629 SHUTE LANE OLD HICKORY TN 37138 US 37138 |
| Brand Name | CLINT PHARMACEUTICALS SINGLE-SHOT EPIDURAL TRAY |
| Generic Name | EPIDURAL INJECTION PROCEDURE TRAY |
| Product Code | OGJ |
| Date Received | 2013-08-16 |
| Lot Number | 2412581 |
| Device Expiration Date | 2015-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | CLINT PHARMACEUTICALS |
| Manufacturer Address | 629 SHUTE LANE OLD HICKORY TN 37138 US 37138 |
| Brand Name | BREVI-KATH MINI KIT; EPIDURAL CATHETER KIT |
| Generic Name | EPIDURAL CATHETER KIT |
| Product Code | BSO |
| Date Received | 2013-08-16 |
| Catalog Number | 181-2393 |
| Lot Number | 31933926 |
| Device Expiration Date | 2015-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | EPIMED INT'L |
| Manufacturer Address | 141 SAL LANDRIO DR JOHNSTOWN NY 12095 US 12095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 8 | 1. Death | 2013-08-16 |