MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-03-12 for 3M MULTIPORE DRY SURGICAL TAPE N/A 3730-0 manufactured by 3m Health Care.
[184050746]
Patient identifier, sex, ethnicity, race: information was not provided by reporter. Sample has not yet been returned for evaluation. Lot number was not provided. The tape was used to secure an endotracheal tube (brand unspecified) while the patient was at the neonatal station in an incubator at 30. 5 degrees c and 45% humidity. The tape was used for approximately 24 hours prior to observation of the issue, and was reported to have stretched and lost adherence; adhesive was observed on the skin.
Patient Sequence No: 1, Text Type: N, H10
[184050747]
Received from (b)(6): customer reported 3m? Multipore? Dry surgical tape that was used to secure an endotracheal tube for a (b)(6) old infant who was in an incubator in a neonatal station slipped, stretched and lost adherence approximately 24 hours after application. Adhesive was observed on the patient's skin. The tube was dislocated and re-taped several times before it was re-affixed with a non-3m brand tape. No extubation or patient injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2020-00016 |
| MDR Report Key | 9825410 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DIANNE GIBBS |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 7379117 |
| Manufacturer G1 | 3M JAPAN PRODUCT LIMITED |
| Manufacturer Street | 5500 OOAZA-OSANAGI HIGASHINE-SHI |
| Manufacturer City | YAMAGATA, 999-3737 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 999-3737 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M MULTIPORE DRY SURGICAL TAPE |
| Generic Name | 3M MULTIPORE DRY TAPE |
| Product Code | KGX |
| Date Received | 2020-03-12 |
| Model Number | N/A |
| Catalog Number | 3730-0 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |