MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-10-13 for DYNA-FLEX COHESIVE COMPRESSION BANDAGES 99999D34 manufactured by Ethicon, Inc..
[17036510]
It was reported by the consumer that the dressing was placed on her right leg and extended from her toes to her knee. The consumer reported experiencing some pain after the dressing was applied and did not report this to her dr. This dressing was in place for one week. When the dressing was removed, the consumer reported that there was a burned or irritated area around her right ankle except for 1/2 an inch in the back. This area was reddened and some skin has since come off in this area. The dermatologist prescribed a topical cream to use on reddened areas.
Patient Sequence No: 1, Text Type: D, B5
[17302922]
Conclusion: no conclusion can be drawn at this time. Should additional info be obtained, a supplemental 3500a form will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2006-00684 |
| MDR Report Key | 769650 |
| Report Source | 04 |
| Date Received | 2006-10-13 |
| Date of Report | 2006-09-15 |
| Date of Event | 2006-03-13 |
| Report Date | 2006-09-15 |
| Date Mfgr Received | 2006-09-15 |
| Date Added to Maude | 2006-10-17 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LUIS BLANCO |
| Manufacturer Street | ROUTE 22 W PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082183002 |
| Manufacturer G1 | BOSS |
| Manufacturer Street | 10 FINNEGAN DR |
| Manufacturer City | DEL RIO TX 78841 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78841 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DYNA-FLEX COHESIVE COMPRESSION BANDAGES |
| Generic Name | KIT, WOUND DRESSING |
| Product Code | MCY |
| Date Received | 2006-10-13 |
| Model Number | NA |
| Catalog Number | 99999D34 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 757490 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | * SOMERVILLE NJ 088760151 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-10-13 |