MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2002-07-09 for HANDYSEAL FDR4367 manufactured by Conroy Medical Ab.
[260896]
This incident was reported to the baxter u. S. Product surveillance on 8/19/02. It was first reported to baxter europe on 7/4/02. The report stated that the customer had experienced ongoing problems with seal quality when using pall blood bags. The customer believed that if pressure was applied to the sealing head during the sealing process the quality of the seal would improve. Two operators were using their forefingers to apply pressure. Their fingers slipped from the sealing head and came into close proximity to the electrode. In both instances there were wounds and the center mgr stated there was a smell of burning flesh. They were examined by a nurse who reported that the wounds were deep and consistent with electrical burns. The operators were given first aid. No follow-up info was provided regarding these operators. This report is for one incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1420141-2002-00048 |
| MDR Report Key | 412181 |
| Report Source | 01,05 |
| Date Received | 2002-07-09 |
| Date of Report | 2002-07-09 |
| Date of Event | 2002-07-01 |
| Date Mfgr Received | 2002-07-04 |
| Date Added to Maude | 2002-08-26 |
| 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 | 0 |
| Manufacturer Contact | DEBBIE LAHR, MGR |
| Manufacturer Street | RT 120 AND WILSON RD |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704695 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANDYSEAL |
| Generic Name | SEALER |
| Product Code | KSD |
| Date Received | 2002-07-09 |
| Model Number | NA |
| Catalog Number | FDR4367 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 401212 |
| Manufacturer | CONROY MEDICAL AB |
| Manufacturer Address | VALHALLAVAGEN 1 UPPL. VASBY * S-194 63 |
| Baseline Brand Name | HANDYSEAL |
| Baseline Generic Name | HANDYSEAL |
| Baseline Model No | FDR4367 |
| Baseline Catalog No | FDR4367 |
| Baseline ID | SEALER |
| Baseline Device Family | SEALER |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-07-09 |