MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for STERILE GAUZE PADS manufactured by Unk.
[144247653]
Non-stick latex-free pads (multiple brands) all caused blistering of the skin in the past. So we used sterile gauze this time. It also cause blistering around the wound area (contact dermatitis). We have pictures if you want to see. I'm not sure what is in the non-stick pads and the sterile gauze (new from store, several / all brands) that would cause blistering but my son is allergic. In not sure what i'm supposed to use beside cotton fabric strips if he does have an injury /scrape/cut. (b)(6) health. Product type: over-the-counter. Did the problem stop after the person reduced the dose or stopped taking or using the product? No; did the problem return if the person started taking or using the product again? Yes. Frequency: twice a day. How was it used or taken: topical. Date the person started taking or using the product: (b)(6) 2019; date the person stopped taking or using the product: (b)(6) 2019. Reason for use: abrasion. Other frequency: twice a day, topical use. Give best estimate duration: 2 week. Reason for use: abrasion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086374 |
| MDR Report Key | 8582287 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-04-05 |
| Date Added to Maude | 2019-05-06 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STERILE GAUZE PADS |
| Generic Name | GAUZED SPONGE, NON RESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2019-05-03 |
| Lot Number | 238420160215 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | CURAD |
| Generic Name | TAPE AND BANDAGE, ADHESIVE |
| Product Code | KGX |
| Date Received | 2019-05-03 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | CURAD / MEDLINE INDUSTRIES, INC. |
| Brand Name | NON-STICK PADS LATEX FREE STERILE |
| Generic Name | GAUZED SPONGE, NON RESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2019-05-03 |
| Lot Number | 6051602054 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | BAND-AID |
| Generic Name | TAPE AND BANDAGE, ADHESIVE |
| Product Code | KGX |
| Date Received | 2019-05-03 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON CONSUMER INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-03 |