MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-12-10 for 3M TRANSPORE SURGICAL TAPE 1527-1 manufactured by 3m Health Care.
[3099675]
Customer stated an iv was secured with transpore tape during a colonoscopy procedure and alleges within a short time, began to have an "allergic" reaction under the tape which included redness and hives. States he was treated with oral prednisone and symptoms resolved. State has no previous history of reaction to adhesives and is seeking a medical opinion.
Patient Sequence No: 1, Text Type: D, B5
[10362805]
Device not provided to manufacturer for evaluation. Complaint type is e=being monitored and analyzed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2012-00062 |
| MDR Report Key | 2886197 |
| Report Source | 04 |
| Date Received | 2012-12-10 |
| Date of Report | 2012-11-13 |
| Date of Event | 2012-11-06 |
| Date Mfgr Received | 2012-11-13 |
| Date Added to Maude | 2013-01-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN RITTLE, REGULATORY MGR |
| Manufacturer Street | 275-5W-06 |
| Manufacturer City | ST PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517330074 |
| Manufacturer G1 | 3M HEALTH CARE |
| Manufacturer City | ST. PAUL MN 55144100 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55144 1000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M TRANSPORE SURGICAL TAPE |
| Generic Name | UNCLASSIFIED - TAPE |
| Product Code | ITG |
| Date Received | 2012-12-10 |
| Model Number | NA |
| Catalog Number | 1527-1 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN 55144100 US 55144 1000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-12-10 |